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Feasibility of the Application of a new Six-month Treatment for multidrug-resistant tuberculosis (MDR-TB) patients in France (FAST-MDR)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512763-32-00
Acronym
APHP230852
Enrollment
50
Registered
2025-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed at the study sites with rifampicinresistant tuberculosis during the recruitment period will be evaluated for study inclusion.

Brief summary

For BPaLM interventional arm: proportion of study participants achieving sustained treatment success at 18 months after study treatment start, according to 2021 WHO definitions, in the absence of permanent addition of any TB drug to the regimen or >4 consecutive weeks treatment interruption or >4 weeks treatment prolongation. For the historical cohort: proportion of patients achieving treatment success (2021 WHO definitions).

Interventions

DRUGMOXIFLOXACIN
DRUGCLOFAZIMINE
DRUGLINEZOLID
DRUGBEDAQUILINE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
For BPaLM interventional arm: proportion of study participants achieving sustained treatment success at 18 months after study treatment start, according to 2021 WHO definitions, in the absence of permanent addition of any TB drug to the regimen or >4 consecutive weeks treatment interruption or >4 weeks treatment prolongation. For the historical cohort: proportion of patients achieving treatment success (2021 WHO definitions).

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026