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

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. A pragmatic trial was carried out in a tertiary hospital and a secondary health care unit in Rio de Janeiro...

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Published in:PloS one 2015-06, Vol.10 (6), p.e0127588-e0127588
Main Authors: Moreira, Adriana da Silva Rezende, Huf, Gisele, Vieira, Maria Armanda Monteiro da Silva, Costa, Paulo Albuquerque da, Aguiar, Fábio, Marsico, Anna Grazia, Fonseca, Leila de Souza, Ricks, Mônica, Oliveira, Martha Maria, Detjen, Anne, Fujiwara, Paula Isono, Squire, Stephen Bertel, Kritski, Afranio Lineu
Format: Article
Language:English
Subjects:
Acids
Adolescent
Adult
Antitubercular Agents - therapeutic use
Automation
Bacteriological Techniques
Brazil
Cerebrospinal fluid
Clinical trials
Comparative analysis
Data processing
Diagnosis
Female
Health care
HIV
Hospitals
Human immunodeficiency virus
Humans
Laboratories
Low income groups
Lung diseases
Male
Management
Medical diagnosis
Medical schools
Middle Aged
Motivation
Mycobacterium tuberculosis
Mycobacterium tuberculosis - isolation & purification
Patients
Randomization
Reagent Kits, Diagnostic
Secondary Care
Smear
Tertiary Healthcare
Tuberculosis
Tuberculosis - diagnosis
Tuberculosis - drug therapy
Tuberculosis - microbiology
Young Adult
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Summary: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. 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. 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. Controlled-Trials.com ISRCTN79888843.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0127588