Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis (NCT04575519) | Clinical Trial Compass
UnknownPhase 2
Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
Georgia, South Africa354 participantsStarted 2021-03-04
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Adults, 18- 60 years of age
✓. Written informed consent in a language they understand. This includes informed consent to be in the trial and informed consent to collect specimens.
✓. Laboratory confirmed pulmonary TB (with or without extrapulmonary involvement) defined as a hard copy of a sputum laboratory result that reports M. tuberculosis (Mtb) detection by a WHO-recommended assay -both rapid molecular assays or mycobacterial culture with subsequent speciation are acceptable as inclusion criteria.
✓. Women of childbearing potential (including females \<2 years post-menopausal) must have a negative pregnancy test at enrolment.
✓. Participants must be willing to have an HIV test done unless there is compelling evidence that the patient is HIV-infected at the time of randomization.
Exclusion criteria
✕. Has a comorbid condition where treatment with aspirin, ibuprofen or other NSAID is indicated (e.g. cardiovascular disease, rheumatic fever, chronic pain, etc.)
✕. People institutionalized (incarceration in jail or prison, or due to chronic mental illness). If incarcerated during the study, participants may be terminated, those incarcerated in the first 8 weeks of follow up will be late exclusions and replaced\*. Patients either who are planned to be hospitalized or currently hospitalized whilst treated for MDR TB in a TB hospital or ward may be enrolled.
✕. Receipt of multi-drug TB treatment (including rifamycin plus isoniazid preventive treatment regimens) for ≥3 days in the 6 months prior to randomization. Participants who have received ≥3 days of TB preventive treatment in the month prior to TB treatment initiation will also be excluded.
What they're measuring
1
Time to ≥ 67% sustained reduction in the TB score
Timeframe: Week 8 of follow-up
2
Hazard ratio for time to stable culture conversion (SCC)
✕. Currently Pregnancy/breastfeeding. Women who conceive and are found to be pregnant in the first 4 weeks of the trial will be terminated from the trial and excluded from the analysis.
✕. Any of the following laboratory parameters taken prior to randomization:
✕. Co-treatment in the three months prior to randomization, or planned treatment over the course of the trial follow up with any one of the following agents:
✕. History or clinical record of sensitivity, asthma or allergy that could be attributed to NSAIDs