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TERMINATED
NCT04575519
PHASE2

Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis

Sponsor: Fundació Institut Germans Trias i Pujol

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

426

Start Date

2021-03-04

Completion Date

2024-03-04

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

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

Locations (3)

National Center for Tuberculosis and Lung Diseases

Tbilisi, Georgia

Perinatal HIV Unit (PHRU)- Chris Hani Baragwanath Hospital

Soweto, Johannesburg, South Africa

PHRU- Matlosana, Tshepong Hospital MDR Unit

Klerksdorp, Matlosana, South Africa