Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01089218
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2010-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2010-03-14', 'studyFirstSubmitQcDate': '2010-03-17', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of fever', 'timeFrame': '24 hr after bronchoscopy', 'description': 'time frame for body temperature 24hr before and after bronchoscopy every 4hrs'}], 'secondaryOutcomes': [{'measure': 'change of serum cytokines level', 'timeFrame': 'before bronchoscopy and 24hr after bronchoscopy', 'description': 'Time frame for cytokine measurement 24hr before brochoscopy - 1hr after bronchosocpy - 24hr after brochoscopy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bronchoscopy', 'post-bronchoscopy fever', 'pneumonia', 'cytokines', 'amoxicillin/clavulanate', 'prophylaxis'], 'conditions': ['Fever', 'Pneumonia']}, 'referencesModule': {'references': [{'pmid': '21396214', 'type': 'DERIVED', 'citation': 'Park JS, Lee CH, Yim JJ, Yang SC, Yoo CG, Chung HS, Kim YW, Han SK, Shim YS, Kim DK. Impact of antibiotic prophylaxis on postbronchoscopy fever: a randomised controlled study. Int J Tuberc Lung Dis. 2011 Apr;15(4):528-35. doi: 10.5588/ijtld.10.0386.'}]}, 'descriptionModule': {'briefSummary': 'Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients. We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of postbronchoscopic fever and pneumonia.', 'detailedDescription': 'For the population being undergone with bronchoscopy, the clinical signs and procedural measures for complication of bronchoscopy and cytokines will be checked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (aged 18 years or older) who underwent FB\n\nExclusion Criteria:\n\n* concurrent treatment with antibiotics or systemic corticosteroid'}, 'identificationModule': {'nctId': 'NCT01089218', 'briefTitle': 'The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines', 'orgStudyIdInfo': {'id': 'postFB fever'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'control without intervention', 'interventionNames': ['Drug: control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amoxicillin/clavulanate', 'interventionNames': ['Drug: oral amoxicillin/clavulanate 1g (875/125mg)']}], 'interventions': [{'name': 'oral amoxicillin/clavulanate 1g (875/125mg)', 'type': 'DRUG', 'otherNames': ['prophylaxis group'], 'description': 'oral amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB', 'armGroupLabels': ['Amoxicillin/clavulanate']}, {'name': 'control', 'type': 'DRUG', 'description': 'no intervention with the same procedure of FB', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Deog Kyeom Kim, MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul Metropolitan Government, Seoul National University Boramae Medical Center, 39 Boramae-Gil, Dongjak-Gu, Seoul, Republic of Korea 156-707.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Deog Kyeom Kim, MD', 'oldOrganization': 'Seoul Metropolitan Government, Seoul National University Boramae Medical Center'}}}}