Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeut
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health. Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023. Only 44% were diagnosed and put on treatment, the therapeutic success rate of the 2021 cohort is only 68%. In Guin
| Condition(s) | Linezolid, Tuberculosis Multi Drug Resistant Active, Therapeutic Drug Monitoring (TDM) |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health. Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023. Only 44% were diagnosed and put on treatment, the therapeutic success rate of the 2021 cohort is only 68%. In Guinea, the number of patients with MDR-TB is estimated at 450, and the treatment success rate is 74% for the 2021 cohort, primarily with the 9-months short oral regimen. Since 2022, the WHO has recommended the use of the 6-month short course of BPaL/BPaL-M for national tuberculosis control programs and Guinea began implementing this new regime within the programmatic framework starting in January 2025. Linezolid, a key component of new therapeutic regimens such as BPaL/BPaL-M, s |
| Who can participate | Inclusion Criteria: * 1\. Confirmed diagnosis of MDR-TB * 2\. Linezolid prescribed as part of the BPaL/BPaL-M regimen * 3\. Age 15 years or older * 4\. Informed consent obtained from the participant or assent from the parent/legal guardian for participants under 18 years of age. Exclusion Criteria: * 1\. Pregnancy or breastfeeding * 2\. Severe liver or kidney failure * 3\. Known hypersensitivity to linezolid * 4\. Concomitant use of medications with drug interactions potential with linezolid |
| Ages | 15 Years |
| Sex | All |
| Lead sponsor | Marco Schiuma |
| Locations | Conakry, Guinea |
| Start date | 2026-04 |
| NCT ID | NCT07477119 |
| Official listing | https://clinicaltrials.gov/study/NCT07477119 |