Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-28 @ 7:22 PM
Study NCT ID:
NCT01076166
Status:
COMPLETED
Last Update Posted:
2011-04-11
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D013535', 'term': 'Suspensions'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid.', 'description': 'The 6 serious adverse events that occurred in 2 participants and the one non-serious adverse event are summarized.', 'eventGroups': [{'id': 'EG000', 'title': 'Klacid Granules (Total)', 'description': 'Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.', 'otherNumAtRisk': 337, 'otherNumAffected': 1, 'seriousNumAtRisk': 337, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Time From Baseline to Recovery From Fever and Other Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Klacid Granules (Total Number Recovered)', 'description': 'Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information who were in the recovered population.'}, {'id': 'OG001', 'title': 'Klacid Granules (Bronchitis, Recovered)', 'description': 'Participants in the recovered population who had a diagnosis of bronchitis at study entry.'}, {'id': 'OG002', 'title': 'Klacid Granules (Pneumonia, Recovered)', 'description': 'Participants in the recovered population who had a diagnosis of pneumonia at study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.18', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '7.14', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '7.88', 'spread': '1.81', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14 days', 'description': "Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 29 patients were excluded for protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). Average time to recovery was based on 171 recovered patients.'}, {'type': 'SECONDARY', 'title': 'Number and Type of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Klacid Granules (Total)', 'description': 'Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.'}], 'classes': [{'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 14 days', 'description': 'Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who took at least 1 dose of Klacid.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Klacid Granules (Total)', 'description': 'Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Symptoms improved/resolved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'A total of 337 participants were enrolled in the study. 308 were analyzed as 29 participants had protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Klacid Granules (Total)', 'description': 'The per-protocol population (308 participants) of male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'BG000', 'lowerLimit': '0.50', 'upperLimit': '11.90'}]}]}], 'paramType': 'MEDIAN', 'description': 'Based on per protocol population (308 participants).', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '> 6 months to 3 years', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}, {'title': 'Between 3 and 5 years', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}, {'title': '> 5 and < 12 years', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Based on per protocol population (308 participants).', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '161', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Based on per protocol population (308 participants).', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Thailand', 'categories': [{'measurements': [{'value': '308', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Based on per protocol population (308 participants).', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Bronchitis', 'categories': [{'measurements': [{'value': '278', 'groupId': 'BG000'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participant diagnosis at study entry for the per protocol population (308 participants).', 'unitOfMeasure': 'participants'}, {'title': 'Risk Factor--Upper Respiratory Tract Infections', 'classes': [{'title': 'URTI 1 to 2 times per year', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}]}]}, {'title': 'URTI 3 to 6 times per year', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'URTI 7 to 10 times per year', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'URTI > 10 times per year', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'URTI not reported', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The frequency in which participants had experienced upper respiratory tract infections (URTI) in the past, for the per protocol population (308 participants).', 'unitOfMeasure': 'participants'}, {'title': 'Risk Factor--Lower Respiratory Tract Infections', 'classes': [{'title': 'LRTI 1 to 2 times per year', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': 'LRTI 3 to 6 times per year', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'LRTI 7 to 10 times per year', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'LRTI > 10 times per year', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'LRTI not reported', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The frequency in which participants had experienced lower respiratory tract infections (LRTI) in the past, for the per protocol population (308 participants).', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2010-02-24', 'resultsFirstSubmitDate': '2011-01-07', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-10', 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Time From Baseline to Recovery From Fever and Other Symptoms', 'timeFrame': 'Baseline to 14 days', 'description': "Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection."}], 'secondaryOutcomes': [{'measure': 'Number and Type of Adverse Events', 'timeFrame': 'Baseline to 14 days', 'description': 'Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-marketing observational study', 'Lower respiratory tract infections', 'Klacid Granules for Oral Suspension'], 'conditions': ['Lower Respiratory Tract Infection']}, 'descriptionModule': {'briefSummary': "Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Out-patients in Thailand', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with lower respiratory tract infection.\n* Patient is male or female \\> 6 months and \\< 12 years of age.\n* Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients\n* Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information\n\nExclusion Criteria:\n\n* Known hypersensitivity to or previously intolerant of macrolides.\n* Illness severe enough to warrant hospitalization or parenteral therapy.\n* Concomitant use of any of the following medications:\n\n * Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.\n * Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.\n * Colchicine\n * Digoxin\n * Ritonavir.\n* Severe immunodeficiency and chronic disease conditions.\n* Renal or hepatic impairment.'}, 'identificationModule': {'nctId': 'NCT01076166', 'briefTitle': 'Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid Granules for Oral Suspension.', 'orgStudyIdInfo': {'id': 'P10-813'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with lower respiratory tract infection', 'description': 'Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension', 'interventionNames': ['Drug: clarithromycin (Klacid) granules for oral suspension']}], 'interventions': [{'name': 'clarithromycin (Klacid) granules for oral suspension', 'type': 'DRUG', 'otherNames': ['clarithromycin', 'Klacid Granules for Oral Suspension', 'Biaxin XL'], 'description': 'clarithromycin (Klacid) Granules for Oral Suspension', 'armGroupLabels': ['Children with lower respiratory tract infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10110', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27424', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10120', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 46824', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10160', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 16261', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10160', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 46825', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10220', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27428', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10260', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27425', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27423', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10900', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27426', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50180', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 46823', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '86000', 'city': 'Chumphon', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27434', 'geoPoint': {'lat': 10.4957, 'lon': 99.17971}}, {'zip': '86110', 'city': 'Chumphon', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27433', 'geoPoint': {'lat': 10.4957, 'lon': 99.17971}}, {'zip': '30000', 'city': 'Nakhon Ratchasima', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27431', 'geoPoint': {'lat': 14.97066, 'lon': 102.10196}}, {'zip': '43110', 'city': 'Nong Khai', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27441', 'geoPoint': {'lat': 17.87847, 'lon': 102.742}}, {'zip': '65000', 'city': 'Phitsanulok', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27429', 'geoPoint': {'lat': 16.82481, 'lon': 100.25858}}, {'zip': '21000', 'city': 'Rayong', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27432', 'geoPoint': {'lat': 12.68095, 'lon': 101.25798}}, {'zip': '74000', 'city': 'Samutsakorn', 'country': 'Thailand', 'facility': 'Site Reference ID/Investigator# 27430'}], 'overallOfficials': [{'name': 'Savary Om, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Savary Om/ Regional Medical Director', 'oldOrganization': 'Abbott Laboratories'}}}}