drugset / Trial / NCT05007821
Linezolid Dosing Strategies in Drug-Resistant TB
Phase 2
Completed
138 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Otsuka Pharmaceutical Development & Commercialization, Inc. · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two doses of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). This study also measured the level of LZD and BDQ in the participants' blood.
Timeline
- Start
- 2022-09-27
- Primary completion
- 2025-03-14
- Completion
- 2026-01-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 100 mg | Oral |
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Subject | Linezolid | Other / unclassified | 600 mg | Oral |
| Subject | Linezolid | Other / unclassified | 1200 mg | Oral |
| Background | Clofazimine | Small molecule | 100 mg | Oral |
| Background | Clofazimine | Small molecule | 300 mg | Oral |
| Background | Delamanid | Small molecule | 300 mg | Oral |