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Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis

NCT05382312 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2026-06-17

Study results available
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Summary

This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or standard of care, for 14 days, in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants reverted to the standard treatment (RIFAFOUR e-275) once the study treatment (Day 1 to Day 14) was completed.

Conditions

Interventions

DRUG

GSK3036656

GSK3036656 was administered.

DRUG

Bedaquiline

Bedaquiline was administered.

DRUG

Delamanid

Delamanid was administered.

DRUG

RIFAFOUR e-275

RIFAFOUR e-275 was administered.

DRUG

BTZ-043

BTZ-043 was administered.

DRUG

Pretomanid

Pretomanid was administered.

DRUG

Linezolid

Linezolid was administered.

DRUG

Moxifloxacin

Moxifloxacin was administered.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2025-05-27
Completion
2025-05-27

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382312 on ClinicalTrials.gov