Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 1:15 PM
Study NCT ID:
NCT05266066
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
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': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized 1:1 to Clinical observation without antibiotic therapy for VAT vs. 7 day antibiotic course.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nosocomial infections', 'timeFrame': '28 days after randomization', 'description': 'Incidence of culture positive nosocomial infections in 28 days'}, {'measure': 'Adverse events', 'timeFrame': '28 days after randomization', 'description': 'Severe adverse events'}], 'primaryOutcomes': [{'measure': 'Ventilator free days', 'timeFrame': '28 days after randomization', 'description': 'Days alive and free from mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'Ventilator associated pneumonia-free survival (Key secondary outcome)', 'timeFrame': '28 days after randomization', 'description': 'The time between randomization and the diagnostic event of ventilator associated pneumonia or death'}, {'measure': 'Mortality', 'timeFrame': '28 days after randomization', 'description': 'All cause mortality'}, {'measure': 'Ventilator associated pneumonia', 'timeFrame': '14 and 28 days after randomization', 'description': 'Ventilator associated pneumonia incidence'}, {'measure': 'Intensive care unit free days', 'timeFrame': '28 days after randomization', 'description': 'Days alive and free from intensive care unit'}, {'measure': 'Organ dysfunction', 'timeFrame': 'Between randomization and day 7.', 'description': 'Variation in organ dysfunction (measured by the Sequential Organ Failure Assessment Score). Sequential Organ Failure Assessment scores are measured in 6 organ systems (cardiovascular, hematologic, gastrointestinal, renal, pulmonary and neurologic), with each organ scored from 0 to 4, resulting in an aggregated score that ranges from 0 to 24, with higher scores indicating greater dysfunction.'}, {'measure': 'Microbiological isolation of multi-resistant bacteria', 'timeFrame': '28 days after randomization', 'description': 'Microbiological isolation of multi-resistant bacteria. Any isolation of by microbiological cultures of multi-resistant bacteria following the definition:\n\nAcinetobacter baumannii: Resistant to carbapenems and/or polymyxins Pseudomonas aeruginosa: Resistant to carbapenems and/or polymyxins Enterobacteriaceae: Resistant to carbapenems and/or polymyxins (in enterobacteria naturally sensitive to polymyxins) Vancomycin-resistant Enterococcus faecium (VRE) Methicillin/Oxacillin Resistant Staphylococcus aureus (MRSA) Methicillin/Oxacillin-Resistant Coagulase Negative Staphylococcus (MRSA)'}, {'measure': 'Antibiotic free days', 'timeFrame': '28 days after randomization', 'description': 'Days alive and free from antibiotic'}, {'measure': 'Cost analysis', 'timeFrame': 'For the first 28 days after randomization', 'description': 'Cost effectiveness analysis. Direct and indirect hospital costs will be measured and used in the analyses. For that, a local costing system will be built, using the absorption costing methodology (top-down).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibiotics', 'Ventilator associated Tracheobronchitis', 'Mechanical ventilation', 'Critically ill'], 'conditions': ['Ventilator Associated Tracheobronchitis', 'Tracheobronchitis']}, 'referencesModule': {'references': [{'pmid': '39194024', 'type': 'BACKGROUND', 'citation': 'IMPACTO-MR, VATICAN Trial Investigators and BRICNet; Tomazini BM, Besen BAMP, Dietrich C, Gandara APR, Silva DP, Pinheiro CCG, Luz MN, Mattos RR, Reis LFL, Roepke RML, Duarte CSLG, Nassar Junior AP, Veiga VC, Arns B, Nascimento GM, Pereira AJ, Cavalcanti AB, Machado FR, Azevedo LCP. VATICAN (Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation): protocol for a multicenter randomized open-label trial of watchful waiting versus antimicrobial therapy for ventilator-associated tracheobronchitis. Crit Care Sci. 2024 Aug 26;36:e20240029en. doi: 10.62675/2965-2774.20240029-en. eCollection 2024.'}, {'pmid': '36888821', 'type': 'BACKGROUND', 'citation': 'Tomazini BM, Nassar AP Jr, Lisboa TC, Azevedo LCP, Veiga VC, Catarino DGM, Fogazzi DV, Arns B, Piastrelli FT, Dietrich C, Negrelli KL, Jesuino IA, Reis LFL, Mattos RR, Pinheiro CCG, Luz MN, Spadoni CCDS, Moro EE, Bueno FR, Sampaio CSJC, Silva DP, Baldassare FP, Silva ACA, Veiga T, Barbante L, Lambauer M, Campos VB, Santos E, Santos RHN, Laranjeiras LN, Valeis N, Santucci E, Miranda TA, Patrocinio ACLD, Carvalho A, Sousa EMC, Sousa AHF, Malheiro DT, Bezerra IL, Rodrigues MB, Malicia JC, Silva SSD, Gimenes BDP, Sesin GP, Zavascki AP, Sganzerla D, Medeiros GS, Santos RDRMD, Silva FKR, Cheno MY, Abrahao CF, Oliveira Junior HA, Rocha LL, Nunes Neto PA, Pereira VC, Paciencia LEM, Bueno ES, Caser EB, Ribeiro LZ, Fernandes CCF, Garcia JM, Silva VFF, Santos AJD, Machado FR, Souza MA, Ferronato BR, Urbano HCA, Moreira DCA, Souza-Dantas VC, Duarte DM, Coelho J, Figueiredo RC, Foreque F, Romano TG, Cubos D, Spirale VM, Nogueira RS, Maia IS, Zandonai CL, Lovato WJ, Cerantola RB, Toledo TGP, Tomba PO, Almeida JR, Sanches LC, Pierini L, Cunha M, Sousa MT, Azevedo B, Dal-Pizzol F, Damasio DC, Bainy MP, Beduhn DAV, Jatoba JDVN, Moura MTF, Rego LRM, Silva AVD, Oliveira LP, Sodre Filho ES, Santos SSD, Neves IL, Leao VCA, Paes JLL, Silva MCM, Oliveira CD, Santiago RCB, Paranhos JLDR, Wiermann IGDS, Pedroso DFF, Sawada PY, Prestes RM, Nascimento GC, Grion CMC, Carrilho CMDM, Dantas RLAM, Silva EP, Silva ACD, Oliveira SMB, Golin NA, Tregnago R, Lima VP, Silva KGND, Boschi E, Buffon V, Machado AS, Capeletti L, Foernges RB, Carvalho AS, Oliveira Junior LC, Oliveira DC, Silva EM, Ribeiro J, Pereira FC, Salgado FB, Deutschendorf C, Silva CFD, Gobatto ALN, Oliveira CB, Dracoulakis MDA, Alvaia NOS, Souza RM, Araujo LLC, Melo RMV, Passos LCS, Vidal CFL, Rodrigues FLA, Kurtz P, Shinotsuka CR, Tavares MB, Santana IDV, Gavinho LMDS, Nascimento AB, Pereira AJ, Cavalcanti AB. IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):418-425. doi: 10.5935/0103-507X.20220209-pt. Epub 2023 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.', 'detailedDescription': "There is no consensus on the need for antibiotic treatment for ventilator-associated tracheobronchitis (VAT). There's a lack of high-quality clinical data on this subject, and although some observational studies recommend antibiotic treatment for VAT, some guidelines do not. The VATICAN is a prospective, randomized, single-blinded (analysis), non-inferiority trial evaluating antibiotic treatment for patients with ventilator-associated tracheobronchitis. Patients with clinically diagnosed tracheobronchitis will be randomized to receive antibiotics for 7 days versus clinical observation without antibiotic treatment for VAT. The primary hypothesis is that clinical observation without antibiotic treatment is noninferior to 7-day antibiotic course."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to one of the participating ICUs\n* Invasive Mechanical ventilation ≥ 48 hours\n* Available chest imaging of screening day\n* Clinical diagnosis of VAT, defined by the presence of:\n\n 1. Temperature \\>38.0°C or \\<36°C OR leukocytes \\>12000/mL or \\<4000/mL or presence \\>10% of immature forms, AND\n 2. Onset of purulent tracheal secretion, or change in characteristics of the secretion, or increase in the amount of respiratory secretion, or increased need for aspiration\n* Culture of tracheal secretion from the day of screening under analysis or collected for analysis\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Indication of use of antibiotics or use of systemic antibiotics for any indications at the time of screening\n* Hemodynamic instability, defined as hypotension unresponsive to volume expansion or increase in vasopressor dose \\> 0.1mcg/kg/min of noradrenaline or equivalent in the past 6 hours\n* Worsening of gas exchange, defined as an increase in the fraction of inspired oxygen ≥ 20% or an increase in positive end-expiratory pressure (PEEP) ≥ 3 cm of water after a stability period ≥ 2 days\n* Prolonged mechanical ventilation, defined by use of invasive mechanical ventilation for 21 days or more\n* Presence of pulmonary radiological image suggestive of new infectious infiltrate\n* Previous lung disease that makes radiological interpretation for the diagnosis of VAP difficult\n* Previous diagnosis of ventilator associates pneumonia (VAP) during hospitalization\n* Neutropenic patients (neutrophils \\<1000/mL)\n* Known severe immunosuppression\n* Tracheostomized patients at the time of screening\n* Inclusion in the study in the past 30 days\n* Expected limitation of care or early withdrawal of supportive therapies (\\< 7 days)\n* Patients with a survival expectancy of less than 48 hours\n* Refusal of consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT05266066', 'acronym': 'VATICAN', 'briefTitle': 'Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sirio-Libanes'}, 'officialTitle': 'Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis', 'orgStudyIdInfo': {'id': '48749421.0.1001.5461'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical observation without antibiotic therapy for VAT', 'description': 'Patients will receive standard care and no antibiotic therapy for VAT. Antibiotics will be prescribed if other infections and/or organ dysfunction ensues (especially shock) or there is progression to pneumonia', 'interventionNames': ['Other: Clinical observation without antibiotic therapy for VAT']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7 day antibiotic course for VAT', 'description': 'Patients will receive standard care and 7 day course of antibiotic therapy for VAT.', 'interventionNames': ['Other: 7 day antibiotic course for VAT']}], 'interventions': [{'name': 'Clinical observation without antibiotic therapy for VAT', 'type': 'OTHER', 'description': 'Patients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.', 'armGroupLabels': ['Clinical observation without antibiotic therapy for VAT']}, {'name': '7 day antibiotic course for VAT', 'type': 'OTHER', 'description': 'Patients will receive standard care plus 7 day course of antibiotic.', 'armGroupLabels': ['7 day antibiotic course for VAT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fortaleza', 'state': 'Ceará', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Fabio H Lacerda, MD', 'role': 'CONTACT'}], 'facility': 'Hospital OTOClinica', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'city': 'Vila Velha', 'state': 'Espírito Santo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Gedealvares Souza, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Vila Velha', 'geoPoint': {'lat': -20.32972, 'lon': -40.2925}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Claudio Dornas de Oliveira, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Santa Casa de Belo Horizonte', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Nova Lima', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Hugo Urbano', 'role': 'CONTACT'}], 'facility': 'Hospital Vila da Serra', 'geoPoint': {'lat': -19.98556, 'lon': -43.84667}}, {'city': 'Passos', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Vanildes Bernardes', 'role': 'CONTACT'}], 'facility': 'Santa Casa de Misericórdia de Passos', 'geoPoint': {'lat': -20.71889, 'lon': -46.60972}}, {'city': 'São João del Rei', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Jorge Paranhos, MD', 'role': 'CONTACT'}], 'facility': 'Hospital São Joao Del Rei', 'geoPoint': {'lat': -21.13556, 'lon': -44.26167}}, {'city': 'Londrina', 'state': 'Paraná', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Cintia Grion', 'role': 'CONTACT'}], 'facility': 'Hospital Universitário Regional do Norte do Paraná', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'city': 'Maringá', 'state': 'Paraná', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Francielle Pereira, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Municipal de Maringá', 'geoPoint': {'lat': -23.42528, 'lon': -51.93861}}, {'city': 'Olinda', 'state': 'Pernambuco', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carlos Duarte, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Tricentenário', 'geoPoint': {'lat': -8.00889, 'lon': -34.85528}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carla Rynkowski, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Ernesto Dornelles', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Itapetininga', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Vivian Irineu, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Itapetininga', 'geoPoint': {'lat': -23.59167, 'lon': -48.05306}}, {'city': 'Limeira', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Luis Paciencia, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Unimed Limeira', 'geoPoint': {'lat': -22.56472, 'lon': -47.40167}}, {'city': 'Santo André', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Caio Dernandes, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Estadual Mario Covas', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Livia Melro, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Samaritano', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Flávia R Machado, MD', 'role': 'CONTACT'}], 'facility': 'Hospital São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Sorocaba', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Vivian Leoneza, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Santa Casa de Sorocaba', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}], 'centralContacts': [{'name': 'Bruno M Tomazini, MD', 'role': 'CONTACT', 'email': 'bruno.mtomazini@hsl.org.br', 'phone': '5511982839173'}, {'name': 'Bruno AMP Besen, MD', 'role': 'CONTACT', 'email': 'brunobesen@yahoo.com.br'}], 'overallOfficials': [{'name': 'Bruno M Tomazini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Sírio-Libanês'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'One year after study completion.', 'ipdSharing': 'YES', 'description': 'Individual patient data (IPD) might be shared upon request and approval by the study committee after the study completion.', 'accessCriteria': 'Individual patient data might be shared upon request and approval by the study committee after the study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sirio-Libanes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, {'name': 'Hospital do Coracao', 'class': 'OTHER'}, {'name': 'Hospital Moinhos de Vento', 'class': 'OTHER'}, {'name': 'Hospital Alemão Oswaldo Cruz', 'class': 'OTHER'}, {'name': 'BP - A Beneficência Portuguesa de São Paulo', 'class': 'UNKNOWN'}, {'name': 'Brazilian Research in Intensive Care Network (BRICNet)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}