NSAIDS-XDR-TB clinical trial: A randomized pilot study to estimate the potential efficacy and safety of using adjunctive ibuprofen for the treatment of pre-XDR and XDR tuberculosis

We conducted a phase IIA prospective open-label pilot trial (ClinicalTrials.gov: NCT02781909) evaluating adjunctive ibuprofen in adults with pulmonary pre-extensively drug-resistant (pre-XDR) or extensively drug-resistant (XDR) tuberculosis in Georgia. Twenty-eight participants received individualized background anti-tuberculosis regimens alone (n = 14) or with ibuprofen 400 mg daily for 2 months (n = 14) and were followed for 6 months.

The primary efficacy outcome was the proportion of participants showing clinical and/or microbiological benefit, assessed by sputum culture conversion, radiological evolution, and WHO-defined treatment outcomes. Secondary outcomes were safety and tolerability, health-related quality of life, and inflammatory and transcriptomic responses. Adding adjunctive ibuprofen did not improve month-2 sputum culture negativity, time to stable culture conversion, radiological evolution, or final treatment outcomes.