Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)

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.

Timeline

Start

2019-02-25

Primary completion

2020-03-14

Completion

2020-04-14

Publications

• Divala TH, Corbett EL, Kandulu C, Moyo B, MacPherson P, Nliwasa M, French N, Sloan DJ, Chiume L, Ndaferankhande MJ, Chilanga S, Majiga ST, Odland JO, Fielding KL. Trial-of-antibiotics to assist tuberculosis diagnosis in symptomatic adults in Malawi (ACT-TB study): a randomised controlled trial. Lancet Glob Health. 2023 Apr;11(4):e556-e565. doi: 10.1016/S2214-109X(23)00052-9.
• Divala TH, Fielding KL, Sloan DJ, French N, Nliwasa M, MacPherson P, Kandulu CC, Chiume L, Chilanga S, Ndaferankhande MJ, Corbett EL. Accuracy and consequences of using trial-of-antibiotics for TB diagnosis (ACT-TB study): protocol for a randomised controlled clinical trial. BMJ Open. 2020 Mar 25;10(3):e033999. doi: 10.1136/bmjopen-2019-033999.

Drugs

Indications