Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT02074033
Status:
UNKNOWN
Last Update Posted:
2014-03-27
First Post:
2014-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Errors in Prescription Antibiotics in Ventilator-associated Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'No samples will be retained for the study'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-26', 'studyFirstSubmitDate': '2014-02-23', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of Errors in Prescription Antibiotics in Ventilator-associated Pneumonia in Unit of Intensive Care of Clinical Hospital of Federal University of Uberlandia - Brazil', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'Guidelines for the Management of Adults with Hospital-acquired, Ventilator-associated, and Healthcare-associated Pneumonia. American Journal of Respiratory and Critical Care Medicine, New'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'ALVAREZ-LERMA, F. et al. Empiric broad-spectrum antibiotic therapy of nosocomial pneumonia in the intensive care unit: A prospective observational study. Crit Care, London, v.10, n.3, p.1-11, May 2006.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'ANGUS, D.C.et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome and associa¬ted costs of care. Crit Care Med, New York, v.29, n.7, p.1303-1310, Jul 2001.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'BURKE, J.P. Infection control- a problem for patient safety. N Engl J Med, Melbourn, v.348, n.7, p. 651-656, Feb 2003.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'CAMARGO, L. F. A. et al. Ventilator associated pneumonia: comparison between quantitative and qualitative cultures of tracheal aspirates. Critical Care Medicine, New York, v.8, n.6, p. 422-430, Dec 2004.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'EACHEMPATI, S.R. et al. Does de-escalation of antibiotic therapy for ventilator-associated pneumonia affect the likelihood of recurrent pneumonia or mortality in critically ill surgical patients? J Trauma, Baltimore, v.66, n.5, p.1343-1348, May 2009.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'ERBAY, A., BODUR, H., AKINCI, E., ÇOLPAN, A. Evaluation of antibiotic use in intensive care units of a tertiary care hospital in Turkey. Journal of Hospital Infection, New York , v.59, p.53-61, Jan 2005.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'GOMES SILVA, B.N. et al. De-escalation of antimicrobial treatment for adults with sepsis, severe sepsis or septic shock. Cochrane Database Syst Rev, Oxford,v.8, n.12, CD007934, Dec 2010.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'HEENEN, S., JACOBS, F., VINCENT,J-P. Antibiotic strategies in severe nosocomial sepsis: Why do we not de-escalate more often? Crit Care Med, New York, v.40, n.5, p.1404-1409, May 2012 .'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'RELLO, J. et al. De-escalation therapy in ventilator associated pneumonia. Crit Care Med , New York, v.32, n.11, p.2183-2190, Nov 2004.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'SAFDAR, N.; CRNICH, C.J.; MAKI, D.G. The Pathogenesis of Ventilator-Associated Pneumonia: Its Relevance to Developing Effective Strategies for Prevention. Respiratory Care, Philadelphia, v.50, n.6, p.725-739, Jun 2005.'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'WAELE, J.J.D.et al. De-escalation after empirical meropenem treatment in the intensive care unit: Fiction or reality? Journal of Critical Care, Orlando, v.25, n.4, p.641-646, Jan 2010.'}]}, 'descriptionModule': {'briefSummary': 'The infection is a major risk to hospitalized patients, especially those admitted to the Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill patients, increasing costs and prolonging hospitalization hospitalar. The ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection in the ICU, occurring in 9% to 68% of patients with prosthetic ventilatória.Due to the high rate of PAV and mortality related to it, is very important both prescription and administration of antibiotics correctly, as deescalation or escalation according the result of cultures.Therefore, the objectives of this study is assess if whether the antibiotic prescribed of ventilator-associated pneumonia following the orientation of literature. Will also be assessed the rate of PAV in patients critically ill adults, the main microorganisms responsible by PAV and determining antimicrobial susceptibility.', 'detailedDescription': 'In patients who had a diagnosis of ventilator-associated pneumonia by asssistente physician will be assessed initially prescribed antibiotics empirically and what conduct adopted after culture results.\n\nWe will be examined whether the antibiotic prescribed following the orientation of literature, considering the dose, interval between doses, dose adjustment for renal failure infusion time, treatment time and conduct after the culture results (deescalation, escalation or maintenance of antimicrobial initially prescribed ) . The deescalation consists of discontinuing the use of antimicrobial or antibiotic change to another with lower coverage and spectrum is performed, escalation occurs when adding a new antibiotic or antibiotic to change the coverage of other larger spectrum after culture results .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study is a retrospective study to evaluate the use of antibiotics in the ventilator-associated pneumonia (PAV) in the Intensive Care Unit of the Adult Clinical Hospital of the Federal University of Uberlândia. The UnitAdult Intensive Care has complexity level III and consists of 30 beds.O number of statistically significant sample is 130 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be 18 years of age;\n* Having the diagnosis of ventilator-associated pneumonia.\n\nExclusion Criteria:\n\n* Be under 18 years of age;'}, 'identificationModule': {'nctId': 'NCT02074033', 'briefTitle': 'Errors in Prescription Antibiotics in Ventilator-associated Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Uberlandia'}, 'officialTitle': 'Determination of Errors in Prescription Antibiotics in Ventilator-associated Pneumonia in Unit of Intensive Care of Clinical Hospital of Federal University of Uberlandia - Brazil', 'orgStudyIdInfo': {'id': '30121978'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'antibiotics for pneumonia', 'description': 'We will be examined whether the antibiotic prescribed following the orientation of literature, considering the dose, interval between doses, dose adjustment for renal failure infusion time, treatment time and conduct after the culture results (deescalation, escalation or maintenance of antimicrobial initially prescribed )'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38405322', 'city': 'Uberlândia', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Denise Von Dollinger de Brito', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ana Carolina Souza Oliveira', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thúlio Marquez Cunha', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fabiola Alves Gomes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ana Carolina Souza Oliveira', 'geoPoint': {'lat': -18.91861, 'lon': -48.27722}}], 'centralContacts': [{'name': 'Ana Carolina Souza Oliveira', 'role': 'CONTACT', 'email': 'acsouzao@yahoo.com.br', 'phone': '055343182150'}], 'overallOfficials': [{'name': 'Ana Carolina Souza Oliveira', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Uberlandia'}, {'name': 'Denise Von Dollinger de Brito', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Uberlandia'}, {'name': 'Thúlio Marquez Cunha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Uberlandia'}, {'name': 'Fabiola Alves Gomes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Uberlandia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Uberlandia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'graduate student', 'investigatorFullName': 'Ana Carolina Souza Oliveira', 'investigatorAffiliation': 'Federal University of Uberlandia'}}}}