Personalized linezolid dosing with therapeutic drug monitoring during the BPaL regimen for MDR-TB

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional program personalizes linezolid dosing within the WHO-recommended BPaL/BPaL-M regimen using therapeutic drug monitoring (TDM) to guide dose changes. Participants with confirmed MDR-TB who are prescribed linezolid will have blood levels measured and doses adjusted to target safer and effective concentrations. Key outcomes include frequency and severity of known linezolid toxicities (myelosuppression, neuropathy, lactic acidosis) and treatment tolerability during the 6-month regimen. The work is implemented in a programmatic setting in Conakry, Guinea, with eligibility criteria excluding pregnancy, severe organ failure, or interacting medications.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre de Santé de Tombolia
  Conakry, Guinea Recruiting

Study contacts

• Principal investigator: Souleymane Hassane Harouna — Action Daminen Guinée
• Study coordinator: Marco Schiuma
• Email: schiuma.marco@asst-fbf-sacco.it
• Phone: +393284931986

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.