At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Linezolid 600 mg, Linezolid 1200 mg (QD), and 6 other interventions for Tuberculosis, Multidrug-Resistant and 2 related conditions. Completed, enrolled 138 participants across 13 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26
Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4
Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26
Two 100mg tablets taken orally once daily in the morning during weeks 1-8
One 100mg tablet taken orally once daily in the morning during weeks 9-26
Six 50mg tablets taken orally once daily in the morning during weeks 1-26
Three 100mg capsules taken orally once daily in the morning during weeks 1-2
One 100mg capsule taken orally once daily in the morning during weeks 3-26