Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT00462020
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2007-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D000038', 'term': 'Abscess'}], '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'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D006699', 'term': 'Home Care Services'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'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': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009739', 'term': 'Nursing Services'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sspeter@cmh.edu', 'phone': '816-983-6479', 'title': 'Shawn D. St. Peter, MD', 'organization': "Children's Mercy Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'No Adverse Events were recorded', 'eventGroups': [{'id': 'EG000', 'title': 'IV Only', 'description': '5 days of IV antibiotics after appendectomy', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IV and Oral Abx', 'description': "home on oral antibiotics to complete 7 days of treatment when tolerating PO's", 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abscess After Appendectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Only', 'description': '5 days of IV antibiotics after appendectomy'}, {'id': 'OG001', 'title': 'IV and Oral Abx', 'description': "home on oral antibiotics to complete 7 days of treatment when tolerating PO's"}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'unitOfMeasure': 'number of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Only', 'description': '5 days of IV antibiotics after appendectomy'}, {'id': 'OG001', 'title': 'IV and Oral Abx', 'description': "home on oral antibiotics to complete 7 days of treatment when tolerating PO's"}], 'classes': [{'categories': [{'measurements': [{'value': '41.06', 'spread': '15.36', 'groupId': 'OG000'}, {'value': '46.30', 'spread': '19.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Regular Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Only', 'description': '5 days of IV antibiotics after appendectomy'}, {'id': 'OG001', 'title': 'IV and Oral Abx', 'description': "home on oral antibiotics to complete 7 days of treatment when tolerating PO's"}], 'classes': [{'categories': [{'measurements': [{'value': '68.00', 'spread': '35.06', 'groupId': 'OG000'}, {'value': '61.42', 'spread': '32.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay After Operation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Only', 'description': '5 days of IV antibiotics after appendectomy'}, {'id': 'OG001', 'title': 'IV and Oral Abx', 'description': "home on oral antibiotics to complete 7 days of treatment when tolerating PO's"}], 'classes': [{'categories': [{'measurements': [{'value': '6.06', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Healthcare Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Only', 'description': '5 days of IV antibiotics after appendectomy'}, {'id': 'OG001', 'title': 'IV and Oral Abx', 'description': "home on oral antibiotics to complete 7 days of treatment when tolerating PO's"}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'unitOfMeasure': 'Visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Only', 'description': '5 days of IV antibiotics after appendectomy'}, {'id': 'FG001', 'title': 'IV and Oral Abx', 'description': 'home on oral antibiotics to complete 7 days of treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All patients with perforated appendicitis were recruited for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Only', 'description': '5 days of IV antibiotics after appendectomy'}, {'id': 'BG001', 'title': 'IV and Oral Abx', 'description': "home on oral antibiotics to complete 7 days of treatment when tolerating PO's"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '10.1', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '9.9', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2007-04-16', 'resultsFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2007-04-17', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-12-12', 'studyFirstPostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abscess After Appendectomy', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': '1 month'}, {'measure': 'Time to Regular Diet', 'timeFrame': '1 month'}, {'measure': 'Length of Stay After Operation', 'timeFrame': '1 month'}, {'measure': 'Total Healthcare Visits', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['appendicitis, perforation, abscess, treatment'], 'conditions': ['Perforated Appendicitis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to scientifically evaluate two different management strategies for perforated appendicitis.\n\nThe hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic decrease in medical care expenses for the patient.\n\nThe primary outcome variable between the two strategies is abscess rate.', 'detailedDescription': 'This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis. This will be a definitive study.\n\nPower calculation was based on abscess rate in the previous prospective, randomized study we just finished. Our current rate is 18%, or just under one-fifth of the patients. A doubling of this rate to 36% would place just over one third of the patients at risk which would be unacceptable. Using a delta of 0.18 with alpha of 0.05 and power of 0.8, the sample size is 74 patients in each arm. Therefore we will anticipate enrolling 150.\n\nSubjects will be those children who undergo a laparoscopic appendectomy as part of their routine care.\n\nPerforation will be defined as an identifiable hole in the appendix or stool in the abdomen.\n\nThe control group will receive current standard care: ceftriaxone 50mg/kg once a day (maximum dose = 2 grams) and metronidazole 30mg/kg once a day (maximum dose = 1 gram) with once a day dosing for both. The length of antibiotic therapy will be a minimum of 5 days. At that time, if they have been afebrile for at least 24 hours, a white blood cell (WBC) count will be obtained, and if that is within normal limits, the antibiotics will be discontinued and the patient will be discharged. If the WBC is elevated, they will receive another 2 days before recheck, if still elevated, they receive another 3 days and a CT Scan is obtained. If, after 5 days of therapy, the patient remains febrile, therapy will continue until afebrile before a WBC check is performed. This is all our current standard management.\n\nThe experimental group will receive the same combination of antibiotics while in the hospital. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. The home antibiotic regimen will be ampicillin/clavulanic acid (Augmentin®). Augmentin® dose will be 40mg/kg twice a day. They will be asked to bring their pill containers with them to clinic where we will quantify medication compliance.\n\nGiven the purpose of this study is the comparison of oral antibiotics to intravenous antibiotics, an allergy to one of the above medications will not be considered an exclusion criteria. In such cases the patient will be treated with an alternative that offers the same spectrum of coverage, but will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identifiable hole in the appendix or stool in the abdomen at the time of appendectomy\n\nExclusion Criteria:\n\n* Known immune deficiency\n* Abscess identified on pre-op imaging\n* Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).'}, 'identificationModule': {'nctId': 'NCT00462020', 'briefTitle': 'Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis', 'orgStudyIdInfo': {'id': '07 02 031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '5 days of IV antibiotics after appendectomy', 'interventionNames': ['Drug: 5 days of IV antibiotics (ceftriaxone and metronidazole)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': "home on oral antibiotics to complete 7 days of treatment when tolerating PO's", 'interventionNames': ['Drug: Home with oral antibiotics when eating (ampicillin/clavulanic acid)']}], 'interventions': [{'name': '5 days of IV antibiotics (ceftriaxone and metronidazole)', 'type': 'DRUG', 'description': '5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing)', 'armGroupLabels': ['1']}, {'name': 'Home with oral antibiotics when eating (ampicillin/clavulanic acid)', 'type': 'DRUG', 'description': 'Augmentin 40mg/kg BID when tolerating POs to complete 7 days total', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Shawn D St. Peter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}