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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Non-Steroid Anti-Inflammatory drug to be administered as adjunctive therapy
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.
National Center for Tuberculosis and Lung Diseases
Tbilisi, Georgia
Perinatal HIV Unit (PHRU)
Soweto, South Africa
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
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.
Time frame: 6 months
Proportion of pilot study participants showing differences in Health Quality of Life (HQoL).
Outcome measurements: HQoL measures at M2 and M6 relative to baseline.
Time frame: 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.
Time frame: 2 and 6 months
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