Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
NCT ID: NCT04575519
Last Updated: 2024-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
354 participants
INTERVENTIONAL
2021-03-04
2025-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control group
Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks.
Control group
placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks
SoC TB
Standard of Care Tuberculosis treatment
SoC TB + ASA group
Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks.
ASA group
Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily)
SoC TB
Standard of Care Tuberculosis treatment
SoC TB + IBU group
Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks
IBU group
Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily)
SoC TB
Standard of Care Tuberculosis treatment
Interventions
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Control group
placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks
ASA group
Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily)
IBU group
Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily)
SoC TB
Standard of Care Tuberculosis treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent in a language they understand. This includes informed consent to be in the trial and informed consent to collect specimens.
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
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.
18 Years
60 Years
ALL
No
Sponsors
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National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
OTHER
Perinatal HIV Research Unit of the University of the Witswatersrand
OTHER
Fundació Institut Germans Trias i Pujol
OTHER
Responsible Party
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Principal Investigators
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Cristina Vilaplana, MD, PhD
Role: STUDY_CHAIR
Fundació Institut Germans Trias i Pujol
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Neil Martinson, MBBCh MPH
Role: primary
References
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Arias L, Otwombe K, Waja Z, Tukvadze N, Korinteli T, Moloantoa T, Fonseca KL, Pillay N, Seiphetlo T, Ouchi-Vernet D, Siles A, Carabias L, Quinones C, Vashakidze S, Martinson N, Vilaplana C. SMA-TB: study protocol for the 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. Trials. 2023 Jun 28;24(1):435. doi: 10.1186/s13063-023-07448-0.
Related Links
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This CT is part of the project which has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 847762.
CORDIS -CE database -SMA-TB project description
SMA-TB repository
Other Identifiers
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SMA-TB-001
Identifier Type: -
Identifier Source: org_study_id
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