Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
Summary
The purpose of this study is to assess the efficacy and safety of 2 repurposed drugs (acetylsalicylic acid and ibuprofen), for use as adjunct therapy added to, and compared with, the standard of care (SoC) WHO-recommended TB regimen in drug-sensitive (DS) and multi-drug resistant (MDR) TB patients.
Timeline
- Start
- 2021-03-04
- Primary completion
- 2023-12-19
- Completion
- 2024-03-04
Outcome
Missed primary endpoint
Stopped (Enrollment): “The impact of the COVID-19 pandemic on TB diagnosis affected greatly the recruitment rate and posed challenges to the trial's timeline, consuming the funding needed to continue the enrolment.”
registry analysis (superiority test); Control Group vs SoC TB + ASA Group; p = 0.4187; Hazard Ratio (HR) 1.161 (95% CI 0.809 to 1.666); Regression, Cox NCT04575519 ↗
registry analysis (superiority test); Control Group vs SoC TB + IBU Group; p = 0.2334; Hazard Ratio (HR) 1.245 (95% CI 0.868 to 1.786); Regression, Cox NCT04575519 ↗
registry analysis (superiority test); Control Group vs SoC TB + ASA Group; p = 0.8975; Hazard Ratio (HR) 1.023 (95% CI 0.723 to 1.447); Regression, Cox NCT04575519 ↗
registry analysis (superiority test); Control Group vs SoC TB + IBU Group; p = 0.5167; Hazard Ratio (HR) 1.123 (95% CI 0.791 to 1.593); Regression, Cox NCT04575519 ↗
Publications
- Background Arias L, Otwombe K, Waja Z, Tukvadze N, Korinteli T, Moloantoa T, Fonseca KL, Pillay N, Seiphetlo T, Ouchi-Vernet D, Siles A, Carabias L, Quinones C, Vashakidze S, Martinson N, Vilaplana C. SMA-TB: study protocol for the phase 2b randomized double-blind, placebo-controlled trial to estimate the potential efficacy and safety of two repurposed drugs, acetylsalicylic acid and ibuprofen, for use as adjunct therapy added to, and compared with, the standard WHO recommended TB regimen. Trials. 2023 Jun 28;24(1):435. doi: 10.1186/s13063-023-07448-0.
- Background Rudolf F, Joaquim LC, Vieira C, Bjerregaard-Andersen M, Andersen A, Erlandsen M, Sodemann M, Andersen PL, Wejse C. The Bandim tuberculosis score: reliability and comparison with the Karnofsky performance score. Scand J Infect Dis. 2013 Apr;45(4):256-64. doi: 10.3109/00365548.2012.731077. Epub 2012 Oct 31.
- Background Wejse C, Gustafson P, Nielsen J, Gomes VF, Aaby P, Andersen PL, Sodemann M. TBscore: Signs and symptoms from tuberculosis patients in a low-resource setting have predictive value and may be used to assess clinical course. Scand J Infect Dis. 2008;40(2):111-20. doi: 10.1080/00365540701558698.
- Background Cuadras P, Rafart G, Català M, Arias L, Pérez R, Martinson N, Rosenthal A, Gabrielian A, Vashakidze S, Tenesa M, Bechini J, Vilaplana C. RTBES Radiological Index for Quantitative Assessment of Tuberculosis Evolution: Development and Validation. medRxiv 2025.02.14.25322286; doi:10.1101/2025.02.14.25322286.
- Results Arias L, Waja Z, Tukvadze N, Moloantoa T, Otwombe K, Korinteli T, Farrés J, Sopegno C, Gogichadze N, Fonseca KL, Pillay N, Seiphetlo T, Cardona PJ, Carabias L, Siles A, Llavero N, Quiñones C, McShane H, Hanekom W, Dyrhol-Riise AM, Karakousis PC, Charalambous S, Videla S, Vashakidze S, Martinson N, Vilaplana C. Acetylsalicylic Acid and Ibuprofen as Adjunctive Therapy for Tuberculosis. medRxiv 2025.12.01.25341191; doi:10.64898/2025.12.01.25341191