Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-09 @ 12:42 PM
Study NCT ID:
NCT03012360
Status:
TERMINATED
Last Update Posted:
2025-12-11
First Post:
2016-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D015378', 'term': 'Imipenem'}, {'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'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': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'whyStopped': 'lack of inclusion pandemic, investigator reluctance, lower than expected incidence of infection', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients with a transition from VAT to VAP,', 'timeFrame': 'from randomization to day 28 (4 weeks)', 'description': 'VAP is defined using the following criteria:\n\n1. new or progressive pulmonary infiltrate\n2. two of the following criteria: temperature \\>38°C or \\<36.5°C leukocyte count \\>12,000/μL or \\<4,000/μL purulent endotracheal aspirate\n3. positive tracheal aspirate (≥105 cfu/mL) or bronchoalveolar lavage (≥104 cfu/mL).\n\nVAP will be considered as subsequent to VAT, when it is diagnosed \\>24h after VAT occurrence. Only first episodes of VAP diagnosed \\>48h after starting mechanical ventilation will be taken into account.'}], 'secondaryOutcomes': [{'measure': 'duration of mechanical ventilation-free days', 'timeFrame': 'from randomization to day 28 (4 weeks)'}, {'measure': 'duration of antibiotic free-days', 'timeFrame': 'from randomization to day 28 (4 weeks)'}, {'measure': 'length of ICU stay', 'timeFrame': 'from randomization to day 28 (4 weeks)'}, {'measure': 'mortality', 'timeFrame': 'at day 28 and day 90 after randomization'}, {'measure': 'percentage of patients with ICU-acquired colonization related to MDR bacteria', 'timeFrame': 'from randomization to day 28 (4 weeks)'}, {'measure': 'percentage of patients with ventilator-associated events', 'timeFrame': 'from randomization to day 28 (4 weeks)'}, {'measure': 'percentage of patients with ICU-acquired infection related to MDR bacteria', 'timeFrame': 'from randomization to day 28 (4 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infectiology', 'Biology of infectious agents', 'Hygiene', 'Pneumology', 'Critical Care'], 'conditions': ['Mechanical Ventilation Complication', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP).', 'detailedDescription': 'The main objective of this randomized controlled multicenter double-blind trial is to assess the efficiency of two durations (3 or 7 days) of antibiotic treatment for VAT, compared with no antibiotic treatment, in reducing the incidence of transition from VAT to ventilator-associated pneumonia (VAP).\n\nSecondary objectives are to determine the impact of two durations (3 or 7 days) of antibiotic treatment for VAT, compared with no antibiotic treatment, on:\n\n* duration of mechanical-ventilation free days\n* duration of antibiotic free days\n* length of ICU stay\n* mortality at day 28 and day 90\n* incidence of ICU-acquired colonization related to multidrug resistant (MDR) bacteria\n* incidence of ICU-acquired infection related to MDR bacteria\n* incidence of ventilator-associated events After informed consent, patients will be randomized (1:1:1) to receive 0 (control group), 3 or 7 days (experimental groups) of antibiotic treatment for VAT\n\nAntibiotic treatment is standardized, based on the time of onset of VAT, and presence of risk factors for MDR bacteria:\n\n* patients with early-onset VAT with no risk factor for MDR bacteria will receive ceftriaxone (2 g iv every 24h).\n* patients with late-onset VAT (after day 4 of mechanical ventilation), or with at least one risk factor for MDR bacteria will receive imipenem (1 g iv every 8h), and ciprofloxacin (400 mg iv every 8h) as empirical treatment. When methicillin-resistant Staphylococcus aureus is suspected, linezolid (600 mg iv every 12h) will be added to empirical treatment.\n\nPatients randomized in control group will receive 7 days of placebo, and those randomized in the first experimental arm (3 days of antibiotics) will receive 4 days of placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients hospitalized in the ICU with a first episode of VAT diagnosed \\>48 hours after starting invasive mechanical ventilation are eligible for this study.\n\nVAT is defined using the following criteria:\n\n1. absence of new infiltrate on chest X ray\n2. two of the three following conditions: fever \\> 38.5 °C or \\<36.5, leucocyte count \\> than 12 000 cells per μL or \\<than 4000 cells per μL purulent tracheal secretions\n3. and positive tracheal aspirate (≥105 cfu/mL)\n\nExclusion Criteria:\n\n* long-term tracheostomy at ICU admission\n* patients who develop VAP before VAT\n* patients already receiving antibiotics active against all the microorganisms responsible for VAT\n* severe immunosuppression\n* pregnancy or breastfeeding\n* patients \\<18 years\n* patients already included in another study, with potential interaction with the primary objective of the current study\n* known resistance to imipenem and ciprofloxacin of bacteria responsible for VAT\n* treatment limitation decisions\n* moribund patients (likely to die within 24 h)\n* allergy to any of study drugs: hypersensitivity to any carbapenem, severe hypersensitivity (for example anaphylactic reaction or severe cutaneous reaction) to any other antibiotic form beta-lactam group (such as penicillin or cephalosporin), severe hypersensitivity (for example anaphylactic reaction) to any other antibiotic from beta-lactam group (penicillin, monobactam or carbapenem), hypersensitivity to quinolones'}, 'identificationModule': {'nctId': 'NCT03012360', 'acronym': 'TAVeM2', 'briefTitle': 'Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis: a Prospective Randomized Placebo-controlled Double-blind Multicenter Trial', 'orgStudyIdInfo': {'id': '2015_66'}, 'secondaryIdInfos': [{'id': '2016-000735-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'no antibiotic treatment for VAT', 'description': '3 days of placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'antibiotic treatment for 3 days', 'description': 'Patients randomized in one of the two experimental groups will receive 3 days of antimicrobials. Antibiotic treatment is standardized, based on the time of onset of VAT, and presence of risk factors for MDR bacteria:\n\n* patients with early-onset VAT (\\< 5 days of mechanical ventilation), with no risk factor for MDR will receive ceftriaxone .\n* patients with late-onset VAT (≥5 days of mechanical ventilation), or with at least one risk factor for multidrug resistant bacteria will receive imipenem , and ciprofloxacin as empirical treatment.\n\nWhen methicillin-resistant Staphylococcus aureus (MRSA) is suspected linezolid will be added to empirical treatment.\n\n3 days of imipenem and ciprofloxacin with optional linezolid, followed by 4 d of placebo', 'interventionNames': ['Drug: ceftriaxone', 'Drug: ciprofloxacin', 'Drug: imipenem', 'Drug: linezolid', 'Drug: placebo']}], 'interventions': [{'name': 'ceftriaxone', 'type': 'DRUG', 'description': '2 g iv every 24h', 'armGroupLabels': ['antibiotic treatment for 3 days']}, {'name': 'ciprofloxacin', 'type': 'DRUG', 'description': '400 mg iv every 8h', 'armGroupLabels': ['antibiotic treatment for 3 days']}, {'name': 'imipenem', 'type': 'DRUG', 'description': '1 g iv every 8h', 'armGroupLabels': ['antibiotic treatment for 3 days']}, {'name': 'linezolid', 'type': 'DRUG', 'description': '600 mg iv every 12h', 'armGroupLabels': ['antibiotic treatment for 3 days']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'The SSI 0.9% or dextrose 5% used are based on routine procedure in different participating centers.Placebo will be prepared using IV bags, with the same of quantity as IMP', 'armGroupLabels': ['antibiotic treatment for 3 days', 'no antibiotic treatment for VAT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Saad NSEIR, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}