NCT05007821

Linezolid Dosing Strategies in Drug-Resistant TB

A Phase II, Prospective, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety/Tolerability of Two Linezolid Dosing Strategies in Combination With a Short Course Regimen for the Treatment of Drug-Resistant Pulmonary Tuberculosis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug or treatment) of an anti-TB treatment regimen that compares two doses of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). This study will also measure the level of these medicines in the participants' blood.

Detailed description

There is currently no "standard of care" or single standardized treatment regimen recommended for everyone with drug resistant-tuberculosis (DR- TB). Current DR-TB treatments may not be well tolerated and can often have side effects. There is a need to identify drugs with enough anti-TB activity (treatment against TB) and good safety profiles that can improve outcomes in the treatment of DR-TB. The main purpose of this study is to evaluate the efficacy and tolerability of a new shorter course anti-TB treatment regimen that compares two dosing strategies of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). As a secondary aim, the study will also assess the safety (the level and type of side effects from a drug or treatment) of the combination of these drugs. Everyone in the study will take these drugs once a day for the entire treatment period: BDQ, DLM, and CFZ. The difference between the two treatment groups in the study is in how participants will take the fourth drug: LZD. Participants in group A will take one dose of LZD once a day for the entire treatment period. Participants in group B will take a higher dose of LZD once a day for 4 weeks and then continue taking that higher dose of LZD just three times a week for the rest of the treatment period.

Conditions

• Tuberculosis, Multidrug-Resistant
• Tuberculosis
• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	Linezolid 600 mg	One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26
DRUG	Linezolid 1200 mg (QD)	Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4
DRUG	Linezolid 1200 mg (TIW)	Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26
DRUG	Bedaquiline 200 mg	Two 100mg tablets taken orally once daily in the morning during weeks 1-8
DRUG	Bedaquiline 100 mg	One 100mg tablet taken orally once daily in the morning during weeks 9-26
DRUG	Delamanid 300 mg	Six 50mg tablets taken orally once daily in the morning during weeks 1-26
DRUG	Clofazimine 300 mg	Three 100mg capsules taken orally once daily in the morning during weeks 1-2
DRUG	Clofazimine 100 mg	One 100mg capsule taken orally once daily in the morning during weeks 3-26

Timeline

• Start date: 2022-08-11
• Primary completion: 2025-03-14
• Completion: 2026-03-13
• First posted: 2021-08-16
• Last updated: 2025-08-12

Locations

13 sites across 7 countries: Botswana, Brazil, Haiti, Peru, Philippines, South Africa, Thailand

Regulatory

• FDA-regulated drug study