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Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment

RecruitingPhase 4Ages 15 Years - anyAllMarco Schiuma
NCT07477119 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, shows high bactericidal activity, although it is associated with serious adverse effects in a hig

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📋 Eligibility rules (as published)
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
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What it tests

  • Linezolid dose personalization based on TDM
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Where

1 site
Centre de Santé de Tombolia
Conakry, Guinea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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