Could aspirin or ibuprofen help beat TB faster?
NCT ID NCT04575519
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding aspirin or ibuprofen to standard tuberculosis (TB) treatment helps patients recover more quickly. It included 426 adults with drug-sensitive or drug-resistant TB. The trial was terminated early, so the results are not conclusive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acetylsalicylic acid (aspirin) and ibuprofen
- What this could lead to
- If successful, adding common pain relievers could speed up recovery from tuberculosis and reduce treatment time.
- What could go wrong
- The trial was terminated early, so we don't have clear evidence it works. Aspirin and ibuprofen also carry risks like bleeding or stomach issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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426 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Mar 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults, 18- 60 years of age 2. Written informed consent in a language they understand. This includes informed consent to be in the trial and informed consent to collect specimens. 3. 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. 4. Women of childbearing potential (including females \<2 years post-menopausal) must have a negative pregnancy test at enrolment. 5. 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: 1. Has a comorbid condition where treatment with aspirin, ibuprofen or other NSAID is indicated (e.g. cardiovascular disease, rheumatic fever, chronic pain, etc.) 2. 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. 3. 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. 4. 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. 5. Any of the following laboratory parameters taken prior to randomization: * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN); * Total bilirubin \> 2 x ULN; * Neutrophil count ≤ 700 neutrophils /mm3; * Platelet count \< 50,000 cells / mm3 * Haemoglobin concentration less than 8 g/dL * Serum creatinine concentration more than twice the upper limit of normal 6. 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: * anticoagulant therapy * immune modulating therapy (cancer treatments, any oral or daily use of inhaled steroids; * Antacids or proton pump inhibitors - including self-treatment and prescription 7. History or clinical record of sensitivity, asthma or allergy that could be attributed to NSAIDs 8. Weight \< 45kg at baseline. 9. History or clinical record suggestive of any of the following in the past two years: * peptic ulcer disease or gastro-intestinal bleeding, * coagulopathy or other bleeding disorder, * renal disease requiring hospitalization - in addition, any prior record at any time of acute kidney injury will be an exclusion criterion. * liver disease requiring further investigation or hospitalization, * underlying cardiovascular disease or risk factors for cardiovascular disease. 10. Patients with HIV infection (irrespective of ART status) if: * CD4 \<350 cells/mm3 * if on ART, unsuppressed (\>200 copies/ml) viral load * if not on ART, either in the opinion of the attending doctor or according to local ART guidelines, the patient should initiate ART during the 8-week initial placebo or NSAID treatment phase. 11. Alcohol use: potential participant either self-reports or in the investigator's opinion that the patient drinks more than an average of four units/day over a usual week or is a binge drinker (men: 5 or more drinks; women: consume 4 or more drinks, in about 2 hours). 12. Major co-morbid conditions or any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Center for Tuberculosis and Lung Diseases
Tbilisi, Georgia
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PHRU- Matlosana, Tshepong Hospital MDR Unit
Klerksdorp, Matlosana, South Africa
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Perinatal HIV Unit (PHRU)- Chris Hani Baragwanath Hospital
Soweto, Johannesburg, 1864, South Africa
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Other studies related to the condition(s) this trial covers.
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- Can new drug cocktails shorten TB treatment?