NCT04575519

Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 354 (estimated)
• Sponsor: Fundació Institut Germans Trias i Pujol · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

If eligible and informed consent obtained, patients will be randomized 1:1:1 into one of the following 3 arms, to receive: 1. Standard of Care (SoC) TB treatment + placebo twice daily during the first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. (control group). 2. SoC TB treatment + acetylsalicylic acid 300mg twice daily during the first 4 weeks of TB treatment followed by acetylsalicylic acid 300mg once daily for an additional 4 weeks. 3. SoC TB treatment + ibuprofen 400mg twice daily during the first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks.

Conditions

• Tuberculosis, Pulmonary
• Tuberculosis, MDR
• Tuberculosis Infection

Interventions

Type	Name	Description
DRUG	Control group	placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks
DRUG	ASA group	Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily)
DRUG	IBU group	Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily)
DRUG	SoC TB	Standard of Care Tuberculosis treatment

Timeline

• Start date: 2021-03-04
• Primary completion: 2024-10-01
• Completion: 2025-06-01
• First posted: 2020-10-05
• Last updated: 2024-03-25

Locations

3 sites across 2 countries: Georgia, South Africa