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https://www.arca.fiocruz.br/handle/icict/59377
LIQUID VS SOLID CULTURE MEDIUM TO EVALUATE PROPORTION AND TIME TO CHANGE IN MANAGEMENT OF SUSPECTS OF TUBERCULOSIS - A PRAGMATIC RANDOMIZED TRIAL IN SECONDARY AND TERTIARY HEALTH CARE UNITS IN BRAZIL
Mycobacterium-tuberculosis
Multicenter evaluation
Hospitals
Diagnosis
Systems
Samples
Malawi
Tuberculosis
Mycobacterium tuberculosis
Drug therapy
Extensively drug-resistant tuberculosis
Diagnostic medicine
Drug screening
Liquids
Tuberculosis diagnosis and management
Author
Affilliation
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil / Policlínica Augusto Amaral Peixoto. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Policlínica Augusto Amaral Peixoto. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
International Union Against Tuberculosis and Lung Disease. Paris, France.
International Union Against Tuberculosis and Lung Disease. Paris, France.
Liverpool School of Tropical Medicine. Liverpool, United Kingdom.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Fundação Oswaldo Cruz. Centro de Desenvolvimento Tecnológico em Saúde. Rio de Janeiro, RJ, Brasil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil / Policlínica Augusto Amaral Peixoto. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Policlínica Augusto Amaral Peixoto. Rio de Janeiro, RJ, Brazil.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
International Union Against Tuberculosis and Lung Disease. Paris, France.
International Union Against Tuberculosis and Lung Disease. Paris, France.
Liverpool School of Tropical Medicine. Liverpool, United Kingdom.
Federal University of Rio de Janeiro. Medical School. Tuberculosis Academic Program. Rio de Janeiro, RJ, Brazil.
Fundação Oswaldo Cruz. Centro de Desenvolvimento Tecnológico em Saúde. Rio de Janeiro, RJ, Brasil.
Abstract
Background: The use of liquid medium (MGIT960) for tuberculosis (TB) diagnosis was recommended by WHO in 2007. However, there has been no evaluation of its effectiveness on clinically important outcomes. Methods and findings: A pragmatic trial was carried out in a tertiary hospital and a secondary health care unit in Rio de Janeiro City, Brazil. Participants were 16 years or older, suspected of having TB. They were excluded if only cerebral spinal fluid or blood specimens were available for analysis. MGIT960 technique was compared with the Lowenstein-Jensen (LJ) method for laboratory diagnosis of active TB. Primary outcome was the proportion of patients who had their initial medical management changed within 2 months after randomisation. Secondary outcomes were: mean time for changing the procedure, patient satisfaction with the overall treatment and adverse events. Data were analysed by intention-to-treat. Between April 2008 and September 2011, 693 patients were enrolled (348 to MGIT, 345 to LJ). Smear and culture results were positive for 10% and 15.7% of participants, respectively. Patients in the MGIT arm had their initial medical management changed more frequently than those in the LJ group (10.1% MGIT vs 3.8% LJ, RR 2.67 95% CI 1.44-.96, p = 0.002, NNT 16, 95% CI 10-39). Mean time for changing the initial procedure was greater in LJ group at both sites: 20.0 and 29.6 days in MGIT group and 52.2 and 64.3 in LJ group (MD 33.5, 95% CI 30.6-36.4, p = 0.0001). No other important differences were observed.
Conclusions: This study suggests that opting for the MGIT960 system for TB diagnosis provides a promising case management model for improving the quality of care and control of TB.
Keywords
Drug-resistant tuberculosisMycobacterium-tuberculosis
Multicenter evaluation
Hospitals
Diagnosis
Systems
Samples
Malawi
Tuberculosis
Mycobacterium tuberculosis
Drug therapy
Extensively drug-resistant tuberculosis
Diagnostic medicine
Drug screening
Liquids
Tuberculosis diagnosis and management
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