Personalized linezolid dosing with therapeutic drug monitoring during the BPaL regimen for MDR-TB
Tolérance du Linézolide Pendant le Régime BPaL Avec Personnalisation de la Posologie Basée Sur la Surveillance Thérapeutique Des Médicaments (TDM) au Cours du Traitement de la Tuberculose Multirésistante
This project will see if adjusting linezolid doses using therapeutic drug monitoring helps people aged 15 and older in Guinea with multidrug-resistant tuberculosis tolerate the 6-month BPaL regimen with fewer serious side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | ASST Fatebenefratelli Sacco Academic / other |
| Locations | 1 site (Conakry) |
| Trial ID | NCT07477119 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 15 or older in Guinea with confirmed MDR-TB who are prescribed linezolid as part of the BPaL/BPaL-M regimen and can provide informed consent and attend clinic visits for blood sampling.
Not a fit: Patients who are pregnant or breastfeeding, have severe liver or kidney failure, have known hypersensitivity to linezolid, or take contraindicated interacting medications are unlikely to benefit from this personalization approach.
Why it matters
Potential benefit: If successful, TDM-guided dosing could reduce serious linezolid side effects and help more patients complete the shortened BPaL regimen, improving cure rates.
How similar studies have performed: Observational studies and pharmacokinetic analyses have suggested that TDM-guided linezolid dosing can reduce toxicity, but controlled programmatic evidence for TDM within BPaL regimens is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Conakry
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.