Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-31 @ 12:57 PM
Study NCT ID:
NCT02630992
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nader.shaikh@chp.edu', 'phone': '412-692-8111', 'title': 'Nader Shaikh', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected through the end-of-treatment visit. The mean day for this visit was 14.2.', 'eventGroups': [{'id': 'EG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg in two divided doses for 10 days; oral, liquid (formulation 2)', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 38, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Protocol defined diarrhea', 'notes': 'Protocol defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diaper dermatitis', 'notes': 'Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': 'PDD reported', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'PDD not reported', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until day 12.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nProtocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 1.'}, {'type': 'PRIMARY', 'title': 'The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': 'PDD reported', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'PDD not reported', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until day 12.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nProtocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 2.'}, {'type': 'PRIMARY', 'title': 'The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': 'Diaper dermatitis reported', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Diaper dermatitis not reported', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until day 12.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nDiaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 1.'}, {'type': 'PRIMARY', 'title': 'The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': 'Diaper dermatitis reported', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Diaper dermatitis not reported', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until day 12.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nDiaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product..', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 2.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'categories': [{'title': 'Treatment failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Clinical success', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 14.9.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nTreatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 1 who had an end-of-treatment assessment at or before the day 12 visit.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': 'Treatment failure', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Clinical success', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nTreatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 2 who had an end-of-treatment assessment at or before the day 12 visit.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Participants Receiving Formulation 1 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'categories': [{'title': 'Resolution of AOM and improvement of symptoms', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'No resolution of AOM or no improvement of symptoms', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.5.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nAn assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.\n\nThe AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child\'s usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 1 who had a day 7 assessment.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Participants Receiving Formulation 2 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'categories': [{'title': 'Resolution of AOM and improvement of symptoms', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'No resolution of AOM or no improvement of symptoms', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.6.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nAn assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.\n\nThe AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child\'s usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 2 who had a day 7 assessment.'}, {'type': 'SECONDARY', 'title': "The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.69', 'spread': '0.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The end-of-treatment visit. The mean day for this visit was 14.9.', 'description': "Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nThe parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 1 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit.'}, {'type': 'SECONDARY', 'title': "The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'spread': '0.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The end-of-treatment visit. The mean day for this visit was 13.9.', 'description': "Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nThe parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is equal to the number of children receiving formulation 2 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit.'}, {'type': 'SECONDARY', 'title': 'Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': '0.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.36', 'spread': '10.07', 'groupId': 'OG000'}]}]}, {'title': '1.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '2.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.42', 'spread': '5.00', 'groupId': 'OG000'}]}]}, {'title': '3.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.07', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '3.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.78', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '4.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.39', 'spread': '8.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nPlasma concentration of amoxicillin 45 mg/kg/dose was measured.\n\nData points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.', 'unitOfMeasure': 'micrograms per milliliter (mcg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': '0.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.63', 'spread': '3.89', 'groupId': 'OG000'}]}]}, {'title': '1.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.49', 'spread': '1.59', 'groupId': 'OG000'}]}]}, {'title': '2.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.76', 'spread': '6.56', 'groupId': 'OG000'}]}]}, {'title': '2.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.22', 'spread': '7.18', 'groupId': 'OG000'}]}]}, {'title': '3.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.00', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': '3.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.36', 'spread': '1.94', 'groupId': 'OG000'}]}]}, {'title': '4.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.52', 'spread': '4.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.', 'description': 'Participants treated with formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nPlasma concentration of amoxicillin 40 mg/kg/dose was measured.\n\nData points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.', 'unitOfMeasure': 'micrograms per milliliter (mcg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': '0.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1047.67', 'spread': '419.90', 'groupId': 'OG000'}]}]}, {'title': '1.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2050', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '2.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '730.50', 'spread': '442.93', 'groupId': 'OG000'}]}]}, {'title': '3.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '338', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '3.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '842', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '4.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '313.80', 'spread': '146.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nPlasma concentration of clavulanate 1.6 mg/kg/dose was measured.\n\nData points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.', 'unitOfMeasure': 'nanograms per milliliter (ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'classes': [{'title': '0.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '407', 'spread': '335.47', 'groupId': 'OG000'}]}]}, {'title': '1.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '655.50', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': '2.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1125.33', 'spread': '418.49', 'groupId': 'OG000'}]}]}, {'title': '2.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '660.16', 'spread': '389.69', 'groupId': 'OG000'}]}]}, {'title': '3.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '986.95', 'spread': '963.05', 'groupId': 'OG000'}]}]}, {'title': '3.5 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '866.00', 'spread': '534.00', 'groupId': 'OG000'}]}]}, {'title': '4.0 hours (approximate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '555.50', 'spread': '494.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nPlasma concentration of clavulanate 1.425 mg/kg/dose was measured.\n\nData points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.', 'unitOfMeasure': 'nanograms per milliliter (ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Amoxicillin-clavulanate Potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '6-11 months', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': '12-23 months', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Ethnicity was reported by the children's parents.", 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Race was reported by the children's parents.", 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Education', 'classes': [{'categories': [{'title': 'Below high school graduate', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'High school graduate or equivalent', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'College graduate', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Health Insurance', 'classes': [{'categories': [{'title': 'Private', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Public', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Type of health insurance relates to the child's insurance.", 'unitOfMeasure': 'Participants'}, {'title': 'Exposure to Other Children', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Yes', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Exposed to other children is defined as exposure to at least 3 children for at least 10 hours per week.', 'unitOfMeasure': 'Participants'}, {'title': 'Acute Otitis Media Severity of Symptoms (AOM-SOS) Score', 'classes': [{'categories': [{'title': '3-5', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': '6-8', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '9-10', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child\'s usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.', 'unitOfMeasure': 'Participants'}, {'title': 'Mean AOM-SOS Score', 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '2.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child\'s usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.', 'unitOfMeasure': 'AOM-SOS score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Laterality of Acute Otitis Media (AOM)', 'classes': [{'categories': [{'title': 'Unilateral', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Bilateral', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Degree of Tympanic Membrane (TM) Bulging', 'classes': [{'categories': [{'title': 'Slight', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Moderate or marked', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'If a child has unilateral AOM, the degree of bulging reflects the degree of bulging in the ear with AOM. If a child has bilateral AOM, the degree of bulging reflects the degree of bulging in the ear with the greater level of bulging,', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2015-12-11', 'resultsFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-04', 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until day 12.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nProtocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.'}, {'measure': 'The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until day 12.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nProtocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.'}, {'measure': 'The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until day 12.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nDiaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.'}, {'measure': 'The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until day 12.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nDiaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product..'}], 'secondaryOutcomes': [{'measure': 'The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit', 'timeFrame': 'From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 14.9.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nTreatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.'}, {'measure': 'The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit', 'timeFrame': 'From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nTreatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.'}, {'measure': 'The Distribution of Participants Receiving Formulation 1 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.5.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nAn assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.\n\nThe AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child\'s usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.'}, {'measure': 'The Distribution of Participants Receiving Formulation 2 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit', 'timeFrame': 'Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.6.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nAn assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.\n\nThe AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child\'s usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.'}, {'measure': "The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1", 'timeFrame': 'The end-of-treatment visit. The mean day for this visit was 14.9.', 'description': "Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nThe parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively."}, {'measure': "The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2", 'timeFrame': 'The end-of-treatment visit. The mean day for this visit was 13.9.', 'description': "Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nThe parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively."}, {'measure': 'Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1', 'timeFrame': 'From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nPlasma concentration of amoxicillin 45 mg/kg/dose was measured.\n\nData points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.'}, {'measure': 'Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2', 'timeFrame': 'From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.', 'description': 'Participants treated with formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nPlasma concentration of amoxicillin 40 mg/kg/dose was measured.\n\nData points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.'}, {'measure': 'Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1', 'timeFrame': 'From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.', 'description': 'Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.\n\nPlasma concentration of clavulanate 1.6 mg/kg/dose was measured.\n\nData points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.'}, {'measure': 'Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2', 'timeFrame': 'From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.', 'description': 'Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.\n\nPlasma concentration of clavulanate 1.425 mg/kg/dose was measured.\n\nData points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ear infections', 'antibiotics', 'antibiotic resistance', 'pediatrics', 'infants', 'children', 'amoxicillin-clavulanate'], 'conditions': ['Acute Otitis Media']}, 'referencesModule': {'references': [{'pmid': '28438923', 'type': 'DERIVED', 'citation': 'Hoberman A, Paradise JL, Rockette HE, Jeong JH, Kearney DH, Bhatnagar S, Shope TR, Muniz G, Martin JM, Kurs-Lasky M, Haralam M, Pope MA, Nagg JP, Zhao W, Miah MK, Beumer J, Venkataramanan R, Shaikh N. Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00238-17. doi: 10.1128/AAC.00238-17. Print 2017 Jul.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days. Investigators will focus on the proportion of subjects who develop protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the prescription of antifungal medication.', 'detailedDescription': 'Amoxicillin-clavulanate potassium has been shown to be efficacious in eradicating causative pathogens in acute otitis media (AOM) with resulting high clinical cure rates at end-of-treatment (85%). However, relatively high rates (\\~25%) of clinically significant diarrhea have been reported, the occurrence of which has been directly related to the clavulanate potassium component of the drug combination. A reduced concentration of clavulanate potassium in the drug formulation would be expected to have an improved safety profile regarding the occurrence of diarrhea. This study will examine whether the concentration of the clavulanate potassium component of amoxicillin-clavulanate potassium could be reduced in the treatment of children 6 months through 23 months of age diagnosed with AOM using stringent criteria. A total of 75 participants (n=75) with AOM will receive amoxicillin-clavulanate potassium (600 mg/21.5 mg/5 mL; 28:1) administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days.\n\nThe primary outcome measure will be rates of clinically significant diarrhea and diaper dermatitis. These rates will be compared with the rate observed in our previous studies of AOM in children who received amoxicillin-clavulanate potassium (600 mg/42.9 mg/5 mL; 14:1) administered at 90/6.4 mg/kg/day in two divided doses for 10 days.\n\nA subset of this group will have pharmacokinetic studies performed. Each participant that agrees will have a single blood draw (n=50). Investigators will analyze amoxicillin and clavulanate potassium in the blood samples using validated methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: 6 to 23 months\n* Evidence of AOM\n* Recent (within 48 hours) onset of signs and symptoms.\n* Middle ear effusion evidenced by the presence of at least 2 of the following: decreased or absent mobility of the tympanic membrane (TM), yellow of white discoloration of the TM, and/or opacification of the TM\n* Acute inflammation evidenced by one of the following: 1+ bulging of the TM with either intense erythema or otalgia or 2+ or 3+ bulging of the TM\n\nExclusion Criteria:\n\n* Toxic appearance (capillary refill \\>3 seconds, systolic blood pressure \\<60 mm Hg)\n* Inpatient hospitalization\n* Clinical or anatomical characteristics that might obscure response to treatment (e.g., tympanostomy tubes in place, cleft palate, Down syndrome)\n* Sensorineural hearing loss (unilateral or bilateral)\n* Allergy to amoxicillin or amoxicillin clavulanate\n* Recent treatment of AOM within the last 14 days'}, 'identificationModule': {'nctId': 'NCT02630992', 'briefTitle': 'Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media', 'orgStudyIdInfo': {'id': 'PRO15080192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'amoxicillin-clavulanate potassium', 'description': 'amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)', 'interventionNames': ['Drug: Amoxicillin-Clavulanate potassium']}], 'interventions': [{'name': 'Amoxicillin-Clavulanate potassium', 'type': 'DRUG', 'otherNames': ['Augmentin'], 'armGroupLabels': ['amoxicillin-clavulanate potassium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Nader Shaikh, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Pittsburgh School of Medicine; Children's Hospital of Pittsburgh of UPMC"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nader Shaikh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Nader Shaikh', 'investigatorAffiliation': 'University of Pittsburgh'}}}}