Pilot clinical trial of bedaquiline treatment for multibacillary leprosy in Mali

Treatment of multibacillary leprosy with oral bedaquiline for 2 months followed by 1 year of WHO multidrug therapy in Mali

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202408643515316

Enrollment

Registered

2024-08-27

Start date

2018-09-24

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Leprosy

Interventions

Bedaquiline for leprosy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Volunteer who gave informed consent Lepromatous leprosy with BI 4+ No prior treatment for leprosy (MDT or dapsone monotherapy) Aged between 18 – 65 Resident in Mali at known address for duration of trial Available for all medical visits required by trial Accept 2 months' hospitalization for bedaquiline treatment phase Non-tuberculous Pregnancy test negative on inclusion Normal ECG

Exclusion criteria

Exclusion criteria: Prior treatment for leprosy Diabetes Hepatitis B or C Renal failure Arterial hypertension Pancreatitis Cancer Tuberculosis HIV-AIDS Hemoglobinopathy Myopathy Pregnancy Substance abuse Concomitant medication for other health conditions

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of bedaquiline during 8 weeks of monotherapy	—

Secondary

Measure	Time frame
Bactericidal activity as measured primarily by mouse footpad assay but also supported by secondary microbiological and molecular assays	—

Countries

Mali

Contacts

Public ContactRoch Christian Johnson

Medical Director Fondation Raoul Follereau

rochchristianjohnson@gmail.com+22996221132

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026