Tuberculosis, PulmonaryPhase 2SMA-TBNCT04575519
Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
A Phase 2 study testing ASA group, IBU group and SoC TB in people with Tuberculosis, Pulmonary and Tuberculosis, MDR, run by Fundació Institut Germans Trias i Pujol at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tuberculosis, Pulmonary, Tuberculosis, MDR, Tuberculosis Infection
- What is being tested?
- ASA group, IBU group and SoC TB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Mar 2021to 4 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN);
Show all 29Show fewer
- 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
- 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
- History or clinical record of sensitivity, asthma or allergy that could be attributed to NSAIDs
- Weight < 45kg at baseline.
- 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.
- 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.
- 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).
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Africa2 sites
PHRU- Matlosana, Tshepong Hospital MDR Unit
Klerksdorp, Matlosana
Perinatal HIV Unit (PHRU)- Chris Hani Baragwanath Hospital
Soweto, Johannesburg, 1864
About this study
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)
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.
Read the detailed description
If eligible and informed consent obtained, patients will be randomized 1:1:1 into one of the following 3 arms, to receive:
- 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).
- 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.
- 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.
- Being tested
- Control group, ASA group, IBU group, SoC TB
- Keywords
- Tuberculosis, Host-directed therapies, Infectious diseases, Drug-sensitive tuberculosis, Drug-resistant tuberculosis
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Latent Tuberculosis, Tuberculosis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDrug
Also called placebo
placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks
ASA groupDrug
Also called Acetylsalicylic acid (ASA)
Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily)
IBU groupDrug
Also called Ibuprofen (IBU)
Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily)
SoC TBDrug
Also called Standard of Care Tuberculosis treatment
Standard of Care Tuberculosis treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Drug: Control group; Drug: SoC TB |
| SoC TB + ASA group | Experimental | 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. Receives: Drug: ASA group; Drug: SoC TB |
| SoC TB + IBU group | Experimental | 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 Receives: Drug: IBU group; Drug: SoC TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ≥ 67% Sustained Reduction in the TB Score
Time taken to reach 67% sustained reduction in the TB score over the course of TB treatment. Minimum value of the score = 0; Maximum value = 13). Higher scores mean a better or worse outcome. Difference between each intervention arm and control group were analysed. The TB Score has been described to be useful to monitor good response to TB treatment, regardless of HIV status.
Measured: 24 weeks of TB treatment
Time to Stable Culture Conversion (SCC)
Time to SCC is defined as the time until at least 2 consecutive negative cultures for M. tuberculosis at least 4 weeks apart during the first 24 weeks of TB treatment.
Measured: 24 weeks of TB treatment
Secondary outcomes (5)
Time to a Stable Culture Conversion (SCC) at Week 8 and Week 16 After Treatment Initiation
Time to SCC is defined as the time until at least 2 consecutive negative cultures for M. tuberculosis at least 4 weeks apart. For this secondary outcome, differences between groups were analyzed at week 8 and week 16
Measured: Week 8 and Week 16
Improvement or Resolution of Clinical Signs and Symptoms
Signs and symptoms were assessed using the TB Score (TBS), which ranges from 0 to 13, with higher scores indicating more severe disease. The outcome was defined as the proportion of participants achieving a ≥50% reduction from baseline in TBS at Week 8 and a ≥75% reduction from baseline in TBS at Week 24. Comparisons were performed between each intervention arm and the control group. TBS has been described as a useful tool for monitoring clinical response to tuberculosis treatment.
Measured: Baseline, week 8 and week 24
Improvement of Lung Function
Improvement of lung function in the 1-second forced expiratory volume (FEV1)
Measured: Baseline, week 8 and week 24
Reduction of the Activity Component of the RTBES
Changes in chest X-ray (CXR) findings were assessed using the Activity component of the RUTI TB Evolution Score (RTBES). The baseline CXR served as the reference for comparison with subsequent CXRs obtained during tuberculosis treatment. The Activity component ranges from 0 to 38, with higher scores indicating more severe radiographic involvement.
The outcome was defined as the proportion of participants achieving a ≥50% reduction from baseline in the Activity component at Week 8 and a ≥75% reduction from baseline at Week 24. Comparisons were performed between each intervention arm and the control group.
Measured: Baseline, week 8 and week 24
Improvement of Health-related Quality of Life
Number of patients showing improvement in health-related quality of life at weeks 8 and 24 compared to baseline, as measured by the Saint Georges Respiratory Questionnaire (SGRQ). The SGRQ score ranges from 0 (best) to 100 (worst), with scores up to 7 considered to be within the healthy range. Improvement in this study being defined as achieving a score within the healthy range.
Measured: Baseline, week 8 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start4 Mar 2021
- Primary completion19 Dec 2023
- Study completion4 Mar 2024
Why it stopped: The impact of the COVID-19 pandemic on TB diagnosis affected greatly the recruitment rate and posed challenges to the trial's timeline, consuming the funding needed to continue the enrolment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, phase IIB, placebo controlled, randomized, 3-arm trial in DS and MDR TB patient
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia, Perinatal HIV Research Unit of the University of the Witswatersrand
- Responsible party
- Sponsor
- Investigators
- Cristina Vilaplana, MD, PhD, Study chair, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575519
- Sponsor's protocol ID
- SMA-TB-001
- Acronym
- SMA-TB
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2020
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37370174Rudolf F, Joaquim LC, Vieira C, Bjerregaard-Andersen M, Andersen A, Erlandsen M, Sodemann M, Andersen PL, Wejse C. The Bandim tuberculosis score: reliability and comparison with the Karnofsky performance score. Scand J Infect Dis. 2013 Apr;45(4):256-64. doi: 10.3109/00365548.2012.731077. Epub 2012 Oct 31.
PubMed 23113626Wejse C, Gustafson P, Nielsen J, Gomes VF, Aaby P, Andersen PL, Sodemann M. TBscore: Signs and symptoms from tuberculosis patients in a low-resource setting have predictive value and may be used to assess clinical course. Scand J Infect Dis. 2008;40(2):111-20. doi: 10.1080/00365540701558698.
PubMed 17852907Cuadras P, Rafart G, Català M, Arias L, Pérez R, Martinson N, Rosenthal A, Gabrielian A, Vashakidze S, Tenesa M, Bechini J, Vilaplana C. RTBES Radiological Index for Quantitative Assessment of Tuberculosis Evolution: Development and Validation. medRxiv 2025.02.14.25322286; doi:10.1101/2025.02.14.25322286.
Arias L, Waja Z, Tukvadze N, Moloantoa T, Otwombe K, Korinteli T, Farrés J, Sopegno C, Gogichadze N, Fonseca KL, Pillay N, Seiphetlo T, Cardona PJ, Carabias L, Siles A, Llavero N, Quiñones C, McShane H, Hanekom W, Dyrhol-Riise AM, Karakousis PC, Charalambous S, Videla S, Vashakidze S, Martinson N, Vilaplana C. Acetylsalicylic Acid and Ibuprofen as Adjunctive Therapy for Tuberculosis. medRxiv 2025.12.01.25341191; doi:10.64898/2025.12.01.25341191
Hogbakk Edlund I, Alonso-Rodriguez N, Sopegno C, Farres J, Gogichadze N, Arias L, Fonseca KL, Otwombe K, Waja Z, Moloantoa T, Pillay N, Seiphetlo T, Martinson N, Vilaplana C, Dyrhol-Riise AM. Dried blood spot IP-10 as a biomarker of tuberculosis severity and treatment responses: results from a phase IIb trial of adjunctive acetylsalicylic acid and ibuprofen. Front Immunol. 2026 Oct 12;17:1924239. doi: 10.3389/fimmu.2026.1924239. eCollection 2026.
PubMed 42935866
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04575519
- Acronym / sponsor ID
- SMA-TB / SMA-TB-001
- Keywords
- Tuberculosis, Host-directed therapies, Infectious diseases, Drug-sensitive tuberculosis, Drug-resistant tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The impact of the COVID-19 pandemic on TB diagnosis affected greatly the recruitment rate and posed challenges to the trial's timeline, consuming the funding needed to continue the enrolment.
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia, Perinatal HIV Research Unit of the University of the Witswatersrand
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If eligible and informed consent obtained, patients will be randomized 1:1:1 into one of the following 3 arms, to receive:
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Multicentre, phase IIB, placebo controlled, randomized, 3-arm trial in DS and MDR TB patient
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Control group, Drug: SoC TBStandard 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. |
| SoC TB + ASA group | Experimental | Drug: ASA group, Drug: SoC TBStandard 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. |
| SoC TB + IBU group | Experimental | Drug: IBU group, Drug: SoC TBStandard 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupAlso: placeboplacebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks | Drug | Control group |
| ASA groupAlso: Acetylsalicylic acid (ASA)Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) | Drug | SoC TB + ASA group |
| IBU groupAlso: Ibuprofen (IBU)Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) | Drug | SoC TB + IBU group |
| SoC TBAlso: Standard of Care Tuberculosis treatmentStandard of Care Tuberculosis treatment | Drug | Control group, SoC TB + ASA group, SoC TB + IBU group |
Primary outcome
Time to ≥ 67% Sustained Reduction in the TB Score
Time frame: 24 weeks of TB treatment
Time taken to reach 67% sustained reduction in the TB score over the course of TB treatment. Minimum value of the score = 0; Maximum value = 13). Higher scores mean a better or worse outcome. Difference between each intervention arm and control group were analysed. The TB Score has been described to be useful to monitor good response to TB treatment, regardless of HIV status.
Time to Stable Culture Conversion (SCC)
Time frame: 24 weeks of TB treatment
Time to SCC is defined as the time until at least 2 consecutive negative cultures for M. tuberculosis at least 4 weeks apart during the first 24 weeks of TB treatment.
5 secondary outcomes
Time to a Stable Culture Conversion (SCC) at Week 8 and Week 16 After Treatment Initiation
Time frame: Week 8 and Week 16
Improvement or Resolution of Clinical Signs and Symptoms
Time frame: Baseline, week 8 and week 24
Improvement of Lung Function
Time frame: Baseline, week 8 and week 24
Reduction of the Activity Component of the RTBES
Time frame: Baseline, week 8 and week 24
Improvement of Health-related Quality of Life
Time frame: Baseline, week 8 and week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37370174Arias 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.
- Background: PubMed 23113626Rudolf F, Joaquim LC, Vieira C, Bjerregaard-Andersen M, Andersen A, Erlandsen M, Sodemann M, Andersen PL, Wejse C. The Bandim tuberculosis score: reliability and comparison with the Karnofsky performance score. Scand J Infect Dis. 2013 Apr;45(4):256-64. doi: 10.3109/00365548.2012.731077. Epub 2012 Oct 31.
- Background: PubMed 17852907Wejse C, Gustafson P, Nielsen J, Gomes VF, Aaby P, Andersen PL, Sodemann M. TBscore: Signs and symptoms from tuberculosis patients in a low-resource setting have predictive value and may be used to assess clinical course. Scand J Infect Dis. 2008;40(2):111-20. doi: 10.1080/00365540701558698.
- BackgroundCuadras P, Rafart G, Català M, Arias L, Pérez R, Martinson N, Rosenthal A, Gabrielian A, Vashakidze S, Tenesa M, Bechini J, Vilaplana C. RTBES Radiological Index for Quantitative Assessment of Tuberculosis Evolution: Development and Validation. medRxiv 2025.02.14.25322286; doi:10.1101/2025.02.14.25322286.
- Results publicationArias L, Waja Z, Tukvadze N, Moloantoa T, Otwombe K, Korinteli T, Farrés J, Sopegno C, Gogichadze N, Fonseca KL, Pillay N, Seiphetlo T, Cardona PJ, Carabias L, Siles A, Llavero N, Quiñones C, McShane H, Hanekom W, Dyrhol-Riise AM, Karakousis PC, Charalambous S, Videla S, Vashakidze S, Martinson N, Vilaplana C. Acetylsalicylic Acid and Ibuprofen as Adjunctive Therapy for Tuberculosis. medRxiv 2025.12.01.25341191; doi:10.64898/2025.12.01.25341191
- Derived from this study: PubMed 42935866Hogbakk Edlund I, Alonso-Rodriguez N, Sopegno C, Farres J, Gogichadze N, Arias L, Fonseca KL, Otwombe K, Waja Z, Moloantoa T, Pillay N, Seiphetlo T, Martinson N, Vilaplana C, Dyrhol-Riise AM. Dried blood spot IP-10 as a biomarker of tuberculosis severity and treatment responses: results from a phase IIb trial of adjunctive acetylsalicylic acid and ibuprofen. Front Immunol. 2026 Oct 12;17:1924239. doi: 10.3389/fimmu.2026.1924239. eCollection 2026.
- 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.Link provided by the sponsor.
- CORDIS -CE database -SMA-TB project descriptionLink provided by the sponsor.
- SMA-TB repositoryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Vilaplana, MD, PhD study chair
Fundació Institut Germans Trias i Pujol
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASA group, IBU group and SoC TB in people with Tuberculosis, Pulmonary and Tuberculosis, MDR, run by Fundació Institut Germans Trias i Pujol at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ≥ 67% Sustained Reduction in the TB Score (time frame: 24 weeks of TB treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575519, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.