Impact of Point-of-care Xpert MTB/RIF on Tuberculosis Treatment Initiation: A Cluster Randomised Trial.


Lessells, RJ; Cooke, GS; McGrath, N; Nicol, MP; Newell, ML; Godfrey-Faussett, P; (2017) Impact of Point-of-care Xpert MTB/RIF on Tuberculosis Treatment Initiation: A Cluster Randomised Trial. American journal of respiratory and critical care medicine. ISSN 1073-449X DOI: https://doi.org/10.1164/rccm.201702-0278OC

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Abstract

Point-of-care (POC) diagnostics have potential to reduce pre-treatment loss to follow-up and delays to initiation of appropriate TB treatment. To evaluate the effect of a POC diagnostic strategy on initiation of appropriate TB treatment. A cluster randomised trial of adults with cough who were HIV positive and/or at high risk of drug-resistant TB. Two-week time blocks were randomised to two strategies (i) Xpert performed at district hospital laboratory (ii) POC Xpert performed at primary health care clinic. All participants provided two sputum specimens: one for Xpert and the other for culture as reference standard. The primary outcome was the proportion of culture-positive pulmonary TB (PTB) cases initiated on appropriate TB treatment within 30 days. Between August 22, 2011 and March 1, 2013, 36 two-week blocks were randomised and 1297 individuals were enrolled (646 in the laboratory arm, 651 in the POC arm); 159 (12.4%) had culture-positive PTB. The proportion of culture-positive PTB cases initiated on appropriate TB treatment within 30 days was 76.5% in the laboratory arm and 79·5% in the POC arm (odds ratio 1·13, 95% confidence interval [CI] 0·51-2.53, p = 0·76; risk difference 3.1%, 95% CI -16.2, 10.1). The median time to initiation of appropriate treatment was 7 days (laboratory) vs. 1 day (POC). POC positioning of Xpert led to more rapid initiation of appropriate TB treatment. Achieving one-stop diagnosis and treatment for all people with TB will require simpler, more sensitive diagnostics and broader strengthening of health systems. Clinical trial registration available at www.isrctn.com, ID ISRCTN18642314.

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
PubMed ID: 28727491
Web of Science ID: 412383800020
URI: http://researchonline.lshtm.ac.uk/id/eprint/4121148

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