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 (SMA-TB)

NCT04575519 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Fundació Institut Germans Trias i Pujol
Phase	Phase 2
Status	UNKNOWN
Enrolment	354
Start date	2021-03-04
Completion	2025-06

Conditions

• Tuberculosis, Pulmonary
• Tuberculosis, MDR
• Tuberculosis Infection

Interventions

• Control group
• ASA group
• IBU group
• SoC TB

Primary outcomes

• Time to ≥ 67% sustained reduction in the TB score — Week 8 of follow-up
  Time to ≥ 67% sustained reduction in the TB score over the course of TB treatment
• Hazard ratio for time to stable culture conversion (SCC) — 24 weeks of TB treatment
  Hazard ratio for time to stable culture conversion (SCC), at least 2 consecutive negative cultures for M. tuberculosis at least 4 weeks apart during the first 24 weeks of TB treatment.

Countries

Georgia, South Africa