XACT-2
Trial question
Is on-site DNA-based molecular testing superior to same-day smear microscopy in patients with at least one tuberculosis symptom?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
65.0% female
35.0% male
N = 584
584 patients (381 female, 203 male).
Inclusion criteria: adult patients with at least one tuberculosis symptom for ≥ 2 weeks or with HIV infection.
Key exclusion criteria: attended a tuberculosis clinic for their symptoms; receipt of tuberculosis treatment.
Interventions
N=288 GeneXpert testing (on-site DNA-based molecular testing).
N=296 smear microscopy (use of conventional point-of-care smear microscopy).
Primary outcome
Median time to initiation of tuberculosis treatment
8 days
41 days
41.0 days
30.8 days
20.5 days
10.3 days
0.0 days
GeneXpert
testing
Smear
microscopy
Significant
decrease ▼
Significantly shorter median time to initiation of tuberculosis treatment (8 days vs. 41 days; AD -33 days, 95% CI -53.88 to -12.12).
Secondary outcomes
Significantly shorter median time to treatment of probably infectious patients (7 days vs. 24 days; AD -17 days, 95% CI -31.34 to -2.66).
Significant increase in the rate of culture-positive patients initiating treatment within 60 days of testing (50% vs. 23%; RR 2, 95% CI 1 to 4.3).
Significant increase in the proportion of potentially infectious patients detected (94.1% vs. 23.5%; RR 3.4, 95% CI 1.6 to 7.2).
Conclusion
In adult patients with at least one tuberculosis symptom for ≥ 2 weeks or with HIV infection, GeneXpert testing was superior to smear microscopy with respect to median time to initiation of tuberculosis treatment.
Reference
Aliasgar Esmail, Philippa Randall, Suzette Oelofse et al. Comparison of two diagnostic intervention packages for community-based active case finding for tuberculosis: an open-label randomized controlled trial. Nat Med. 2023 Apr;29(4):1009-1016.
Open reference URL