Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)
Status:
Completed
Trial end date:
2020-04-14
Target enrollment:
Participant gender:
Summary
This is a three-arm, open-label individually randomised controlled clinical trial
investigating the benefits of the diagnostic use of broad-spectrum antimicrobials during the
diagnostic process for tuberculosis (TB) and the risk of antimicrobial resistance. Adults
(≥18 years) presenting to primary care with TB symptoms will, after excluding acute illness,
be randomised (1:1:1) to receiving azithromycin, amoxicillin or standard care. Diagnostic
accuracy will be ascertained by comparing self-reported response to treatment on Day-8 to
results of mycobacteriology tests (MTB culture, smear microscopy and Xpert/MTB/RIF).
Antimicrobial resistance will be ascertained by comparing arms with respect to incidence of
resistant Streptococcus pneumonia carriage cultured from nasopharyngeal swabs collected on
Day-28. Clinical benefit will be ascertained by comparing clinical outcomes by Day-29.