Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT04301869
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2020-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment feasibility', 'timeFrame': '3 months', 'description': 'Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure'}, {'measure': 'Completion feasibility', 'timeFrame': '3 months', 'description': 'Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call'}], 'secondaryOutcomes': [{'measure': 'Treatment failure', 'timeFrame': '3 months', 'description': 'Treatment failure at the 3-month clinical visit or phone conversation, defined as any of: (i) return to the emergency department for new fever, shortness of breath or progressive hypoxia OR (ii) radiological progression of empyema or development of a new abscess OR (iii) mortality related to pleural space infection. Treatment failure must be agreed upon by the majority of the adjudication committee.'}, {'measure': 'Mortality', 'timeFrame': '3 months', 'description': 'All-cause mortality at 3 months'}, {'measure': 'Antibiotic duration', 'timeFrame': '3 months', 'description': 'Duration of antibiotics with start date as the date of randomization'}, {'measure': 'Hospitalization duration', 'timeFrame': '3 months', 'description': 'Duration of hospitalization'}, {'measure': 'Stopping antibiotics', 'timeFrame': '3 months', 'description': 'Early termination of antibiotics due to patient intolerance, patient preference or any other reason.'}, {'measure': 'IV line complications', 'timeFrame': '3 months', 'description': 'Infection, thrombosis or new line placement for IV catheter-related issues.'}, {'measure': 'C. difficile', 'timeFrame': '3 months', 'description': 'Clostridium difficile associated diarrhea as per the accepted PIDAC definition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pleural Infection']}, 'descriptionModule': {'briefSummary': 'We aim to conduct a pilot trial assessing oral versus intravenous therapy for pleural space infections.', 'detailedDescription': 'Pleural space infections are a frequent clinical problem resulting in significant morbidity and mortality as well as healthcare cost. Despite the increasing burden of disease, there are no clinical trials evaluating antibiotic therapy in pleural space infections. Hence, British and American guidelines are only able to provide weak and vague recommendations regarding duration, type or route (intravenous or oral) of antibiotic therapy. Our goal is to determine whether oral (PO) therapy is non-inferior to intravenous (IV) therapy thereby decreasing risks of IV catheter related infections, vein thrombosis and health care costs. Similar studies have been successfully conducted in the setting of bone/joint infections and endocarditis and showed non-inferiority of oral antibiotics. However, in order to help ensure that the randomized trial is of good quality, it is important to assess the feasibility of such a trial by first conducting a pilot study. The goal of this pilot trial is to assess the feasibility of the proposed study design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must meet our study definition of pleural space infection\n* Age \\> or = 18 years old\n* Life expectancy \\> 1 year\n* Received intravenous or oral antibiotics for = or \\< 7 d from surgical intervention or received a total of = or \\< 7 d of antibiotics if no intervention performed\n\nExclusion Criteria:\n\n* S. aureus bacteremia or endocarditis in the last 1 month\n* Another concomitant infection requiring prolonged IV antibiotics\n* Esophageal rupture or malignant pleural effusion\n* Septic shock or systemic features requiring IV antibiotics\n* Mycobacterial, fungal or parasitic pleural space infection\n* No oral antibiotic options available\n* Unlikely to comply with therapy'}, 'identificationModule': {'nctId': 'NCT04301869', 'briefTitle': 'Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Healthcare Hamilton"}, 'officialTitle': 'Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'PSI Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous therapy', 'description': 'Intravenous antibiotics administered for pleural space infection', 'interventionNames': ['Drug: Antibiotics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral therapy', 'description': 'Oral antibiotics administered for pleural space infection', 'interventionNames': ['Drug: Antibiotics']}], 'interventions': [{'name': 'Antibiotics', 'type': 'DRUG', 'description': 'Oral versus intravenous therapy', 'armGroupLabels': ['Intravenous therapy', 'Oral therapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, 'collaborators': [{'name': 'Vaibhav Mokashi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Phillipe El-Helou', 'investigatorAffiliation': "St. Joseph's Healthcare Hamilton"}}}}