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| Name | Class |
|---|---|
| National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia | OTHER |
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Novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the duration of TB treatment) and to treat XDR-TB cases are urgently required. Host-Directed therapies (especially repurposed drugs such as Non-Steroid AntiInflammatory Drugs NSAIDS) could be useful in this context, and therefore the appropriateness and potential effect of this approach needs to be evaluated in humans. Investigators do propose a prospective, randomized, pilot study to estimate the potential efficacy and safety of using adjunctive ibuprofen for the treatment of XDR tuberculosis.
There are a need for novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the duration of TB treatment) and to treat XDR-TB cases. Host-Directed therapies (especially repurposed drugs such as Non-Steroid AntiInflammatory Drugs NSAIDS) could be useful in this context, and therefore the appropriateness and potential effect of this approach needs to be evaluated in humans. Investigators do propose a prospective, randomized, pilot clinical trial to evaluate the potential efficacy and safety of using adjunctive ibuprofen during two months for the treatment of XDR tuberculosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Standard of Care TB treatment | Active Comparator | Individuals with confirmed pulmonary XDR-TB and receiving Standard of Care TB treatment according to national and WHO guidelines; n=12 |
|
| Ibuprofen-treated | Experimental | Individuals with confirmed pulmonary XDR-TB and receiving Standard of Care TB treatment according to national and WHO guidelines plus ibuprofen (400mg/day/2 months); n=12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Non-Steroid Anti-Inflammatory drug to be administered as adjunctive therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of pilot study participants with microbiological efficacy-related events that are related to treatment. | Number of pilot study participants with negative sputum culture at M2 and M6 following inclusion | 6 months |
| Number of pilot study participants with radiological efficacy-related events that are related to treatment. | Changes detected by X-ray during follow-up up to month 6 | 6 months: at baseline, at month 3 and month 6 |
| Number of pilot study participants with clinical efficacy-related events that are related to treatment. | Final treatment outcomes according to the WHO definitions including all time in follow-up to M6 on TB treatment | 6 months |
| Microbiological efficacy-related events: Time to stable culture conversion up to M6 | Time to stable culture conversion up to M6: (≥ two consecutive cultures negative for M. tuberculosis) including all time in follow-up to month six on TB treatment. Differences between the two groups | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pilot study participants with Safety-related events. | Outcome measurements: incidence of safety-related events during the whole study period: clinical worsening of the disease, no sputum conversion (if AFS-), any worsening concerning vital parameters and routine blood work. | 6 months |
| Proportion of pilot study participants showing differences in Health Quality of Life (HQoL). |
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Inclusion Criteria:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Cris Vilaplana, MD, PhD | Fundació Institut Germans Trias i Pujol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Tuberculosis and Lung Diseases | Tbilisi | Georgia | ||||
| Perinatal HIV Unit (PHRU) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42386760 | Derived | Fonseca KL, Farres J, Barbakadze K, Jikia I, Tsotskhalashvili M, Garcia-Illarramendi JM, Arias L, Otwombe K, Sopegno C, Despuig A, Martinson N, Buhiichyk N, Korinteli T, Layre E, Nigou J, Avaliani Z, Tukvadze N, Vashakidze S, Vilaplana C. Adjunctive ibuprofen in pre-extensively drug-resistant and extensively drug-resistant tuberculosis: a phase IIA open-label pilot clinical trial. Nat Commun. 2026 Jul 1. doi: 10.1038/s41467-026-75148-9. Online ahead of print. |
| Label | URL |
|---|---|
| Experimental Tuberculosis Unit of the Germans Trias i Pujol website (PI's affiliation) | View source |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Standard of Care TB treatment | Drug | Standard of Care (SoC) TB Treatment will be optimized and drugs selected according to the National and WHO Guidelines, sensitivity profile and as per routine. |
|
|
Outcome measurements: HQoL measures at M2 and M6 relative to baseline. |
| 2 and 6 months |
| Proportion of pilot study participants showing differences in Immune Responses at M2 and M6 relative to baseline. | Outcome measurements: changes detected in immune responses at M2 and M6. | 2 and 6 months |
| Soweto |
| 1862, |
| South Africa |
| Host-Directed Therapies Network website | View source |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018712 |
| Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |