11 research outputs found
Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial
Background: Xpert MTB/RIF is approved for use in tuberculosis (TB) and rifampicin-resistance diagnosis. However, data are limited on the impact of Xpert under routine conditions in settings with high TB burden. Methods and Findings: A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive (symptomatic) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic. The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by 3 mo after presentation. Secondary outcomes included time to TB treatment and mortality. Unblinded randomisation occurred on a weekly basis. Xpert and smear microscopy were performed on site. Analysis was both by intention to treat (ITT) and per protocol. Between 7 September 2010 and 28 October 2011, 1,985 participants were assigned to the Xpert (n = 982) and routine (n = 1,003) diagnostic algorithms (ITT analysis); 882 received Xpert and 1,063 routine (per protocol analysis). 13% (32/257) of individuals with bacteriologically confirmed TB (smear, culture, or Xpert) did not initiate treatment by 3 mo after presentation in the Xpert arm, compared to 25% (41/167) in the routine arm (ITT analysis, risk ratio 0.51, 95% CI 0.33–0.77, p = 0.0052). The yield of bacteriologically confirmed TB cases among patients with presumptive TB was 17% (167/1,003) with routine diagnosis and 26% (257/982) with Xpert diagnosis (ITT analysis, risk ratio 1.57, 95% CI 1.32–1.87, p<0.001). This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm: 23% (229/1,003) and 28% (277/982) in the routine and Xpert arms, respectively (ITT analysis, risk ratio 1.24, 95% CI 1.06–1.44, p = 0.013). Time to treatment initiation was improved overall (ITT analysis, hazard ratio 0.76, 95% CI 0.63–0.92, p = 0.005) and among HIV-infected participants (ITT analysis, hazard ratio 0.67, 95% CI 0.53–0.85, p = 0.001). There was no difference in 6-mo mortality with Xpert versus routine diagnosis. Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic. Conclusions: These data suggest that in this routine primary care setting, use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by 3 mo and reduced time to treatment initiation, particularly among HIV-infected participants
Proportion of participants initiating TB treatment by time to TB treatment initiation for both study arms, ITT analysis (<i>p</i> = 0.0042).
<p>Xpert: solid line; routine: dashed line.</p
TB treatment initiation, overall and by HIV status, in the Xpert and routine arms for both the ITT and per protocol analyses.
<p>TB treatment initiation, overall and by HIV status, in the Xpert and routine arms for both the ITT and per protocol analyses.</p
Proportion of HIV-infected and -uninfected participants initiating TB treatment by time to treatment initiation for both study arms, ITT analysis.
<p>Xpert: solid line; routine: dashed line. (A) HIV-infected individuals (<i>p</i><0.001); (B) HIV-uninfected individuals (<i>p</i> = 0.778).</p
Microbiological results by study arm for both the ITT and per protocol analyses.
<p>Microbiological results by study arm for both the ITT and per protocol analyses.</p
Diagnostic testing algorithm for each study arm.
<p>Diagnostic testing algorithm for each study arm.</p
Treatment outcomes for all participants and HIV-infected participants (excluding rifampicin-resistant TB) by study arm (ITT analysis).
<p>Treatment outcomes for all participants and HIV-infected participants (excluding rifampicin-resistant TB) by study arm (ITT analysis).</p
Participants initiating TB treatment with confirmed TB (bacteriologically positive) and unconfirmed TB, overall and by HIV status (ITT analysis).
<p>Participants initiating TB treatment with confirmed TB (bacteriologically positive) and unconfirmed TB, overall and by HIV status (ITT analysis).</p