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Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis

NCT04575519 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2024-03-25

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Pulmonary
  • Tuberculosis, MDR
  • Tuberculosis Infection

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

Sponsors & Collaborators

  • National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

    collaborator OTHER

  • Perinatal HIV Research Unit of the University of the Witswatersrand

    collaborator OTHER

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Cristina Vilaplana, MD, PhD · Fundació Institut Germans Trias i Pujol

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2024-10-31
Completion
2025-06-30

Countries

  • Georgia
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575519 on ClinicalTrials.gov