Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-13 @ 7:44 PM
Study NCT ID:
NCT03795194
Status:
TERMINATED
Last Update Posted:
2024-03-08
First Post:
2018-07-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antibiotic Duration in Post-appendectomy Abscess
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zhunteman@phoenixchildrens.com', 'phone': '6029331858', 'title': 'Research Coordinator', 'organization': "Phoenix Children's"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Low enrollment. Early termination leading to small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed 30 days post-discharge after abscess drainage.', 'eventGroups': [{'id': 'EG000', 'title': '8-day', 'description': '8-day course of ampicillin clavulanate antibiotic\n\nampicillin/clavulanate: FDA-approved antibiotic', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '4-day', 'description': '4--day course of ampicillin clavulanate antibiotic\n\nampicillin/clavulanate: FDA-approved antibiotic', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Readmission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (8-Day) 30-day Readmission Rate', 'description': 'Rate of readmission to hospital following source control of abscess when treated with antibiotics for 8 days.'}, {'id': 'OG001', 'title': 'Arm B (4-Day) 30-day Readmission Rate', 'description': 'Rate of readmission to hospital following scource control of abscess when treated with antibiotics for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Rate of readmission to the hospital after abscess drainage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (8-day)', 'description': 'Arm A hospital length of stay if readmitted following abscess drainage.'}, {'id': 'OG001', 'title': 'Arm B (4-day)', 'description': 'Arm B hospital length of stay if readmitted following abscess drainage.'}], 'timeFrame': '30 days', 'description': 'How many days patient stays in the hospital if and when they are readmitted after their abscess drainage.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were not readmitted to the hospital after abscess drainage.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '8-day', 'description': '8-day course of ampicillin clavulanate antibiotic\n\nampicillin/clavulanate: FDA-approved antibiotic'}, {'id': 'FG001', 'title': '4-day', 'description': '4--day course of ampicillin clavulanate antibiotic\n\nampicillin/clavulanate: FDA-approved antibiotic'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (8-day)', 'description': 'In this study, all patients will be treated with the hospital standard of care and receive in-patient treatment for abscess until afebrile and tolerating food for 24 hours. After percutaneous drainage of the abscess, the patient will be randomly assigned to receive either an 8-day regimen (arm A) or a 4-day regimen (arm B) of antibiotics (Diagram 1). Patients will remain on IV ceftriaxone/metronidazole or other broad spectrum antibiotic equivalent until afebrile and tolerating food for 24 hours. Patients will complete their assigned 4- or 8-day regimen with oral ampicillin clavulanate or other broad spectrum antibiotic equivalent. If patients are not afebrile at the completion of their assigned regimen, prescribing an extended course of antibiotics is at the discretion of the treating surgeon. A prescribed oral course of antibiotics may be finished in the hospital or at home if patient is discharged.'}, {'id': 'BG001', 'title': 'Arm B (4-day)', 'description': 'In this study, all patients will be treated with the hospital standard of care and receive in-patient treatment for abscess until afebrile and tolerating food for 24 hours. After percutaneous drainage of the abscess, the patient will be randomly assigned to receive either an 8-day regimen (arm A) or a 4-day regimen (arm B) of antibiotics (Diagram 1). Patients will remain on IV ceftriaxone/metronidazole or other broad spectrum antibiotic equivalent until afebrile and tolerating food for 24 hours. Patients will complete their assigned 4- or 8-day regimen with oral ampicillin clavulanate or other broad spectrum antibiotic equivalent. If patients are not afebrile at the completion of their assigned regimen, prescribing an extended course of antibiotics is at the discretion of the treating surgeon. A prescribed oral course of antibiotics may be finished in the hospital or at home if patient is discharged.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.34', 'spread': '2.48', 'groupId': 'BG000'}, {'value': '9.65', 'spread': '3.56', 'groupId': 'BG001'}, {'value': '12.09', 'spread': '4.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-25', 'size': 292904, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-01T16:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Due to low enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2018-07-19', 'resultsFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-05', 'studyFirstPostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Readmission Rate', 'timeFrame': '30 days', 'description': 'Rate of readmission to the hospital after abscess drainage.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': '30 days', 'description': 'How many days patient stays in the hospital if and when they are readmitted after their abscess drainage.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complicated Appendicitis', 'Perforated Appendicitis']}, 'descriptionModule': {'briefSummary': 'This is a randomized study of patients 2-17 years old who are diagnosed with perforated appendicitis and develop an abscess after laparoscopy that is subsequently drained. Patients will be randomized to either receive an 8-day or a 4-day course of antibiotics. The aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in clinical outcomes.', 'detailedDescription': "The central aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in primary and secondary clinical outcomes. Specifically, this research aims to determine whether the readmission rate and length of stay for pediatric patients diagnosed with perforated appendicitis who form a post-laparoscopic abscess that is treated with percutaneous drainage and are treated with a 8-day oral antibiotic regimen at discharge is significantly different from those treated with a fixed 4-day regimen at discharge.\n\nThis study includes patients ages 2-17 years old who present with perforated appendicitis-as diagnosed at laparoscopy and photographed as either a hole or as feces in the abdomen-and who develop an abscess after laparoscopy that is treated with percutaneous drainage.\n\nAll post-laparoscopic abscess patients will receive the standard of care for antibiotic therapy at Phoenix Children's Hospital-IV ceftriaxone/metronidazole-until afebrile and tolerating food. All patients will be treated with the PCH standard of care and receive in-patient treatment for abscess until afebrile.\n\nAt discharge, study patients will be randomly assigned to either an 8-day ampicillin/clavulanate regimen or a 4-day ampicillin/clavulanate regimen. Pediatric patients who are allergic to ampicillin will be excluded from the study. Patients will be followed thirty days post discharge to assess clinical outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 2 to 17 years of age\n* Diagnosis of perforated appendicitis at laparoscopy\n* Development of a post-appendectomy abscess that is treated with percutaneous drainage.\n\nExclusion Criteria:\n\n* Patients who are allergic to ampicillin'}, 'identificationModule': {'nctId': 'NCT03795194', 'briefTitle': 'Antibiotic Duration in Post-appendectomy Abscess', 'organization': {'class': 'OTHER', 'fullName': "Phoenix Children's Hospital"}, 'officialTitle': 'A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess', 'orgStudyIdInfo': {'id': '17-055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '8-day', 'description': '8-day course of ampicillin clavulanate antibiotic', 'interventionNames': ['Drug: ampicillin/clavulanate']}, {'type': 'OTHER', 'label': '4-day', 'description': '4--day course of ampicillin clavulanate antibiotic', 'interventionNames': ['Drug: ampicillin/clavulanate']}], 'interventions': [{'name': 'ampicillin/clavulanate', 'type': 'DRUG', 'otherNames': ['Augmentin'], 'description': 'FDA-approved antibiotic', 'armGroupLabels': ['4-day', '8-day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Craig Egan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Phoenix Children's"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Phoenix Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}