TerminatedPhase 2

Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Stopped: Data generated in the Gates MRI-TBD06-201 trial do not support the investigational regimens being able to achieve the trial objective of identifying a new regimen to treat tuberculosis in 3 months or less.

Philippines, South Africa93 participantsStarted 2023-07-26

Plain-language summary

This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmation of Mtb infection: Mtb positivity on a molecular test (eg, Xpert Ultra, Hain Line probe assay \[LPA\]) conducted on a sputum specimen for trial screening.
✓. Evidence of non-paucibacillary disease: ≥1+ sputum smear positivity for acid-fast bacilli using fluorescent microscopy, as defined by the International Union Against Tuberculosis and Lung Disease (IUATLD)/World Health Organization (WHO) scale, OR a Xpert Ultra semi-quantitative result of 'medium' or 'high' on the sputum specimen for trial screening.
✓. Drug-susceptible TB: Isoniazid and rifampicin resistance not detected, as determined by a molecular test (eg, Hain LPA, Xpert Ultra, Xpert MTB/Extensively Drug Resistant \[XDR\]) conducted on a sputum specimen for trial screening.
✓. Clinical signs and/or symptoms consistent with active TB in the opinion of the Investigator.
✓. Chest radiograph consistent with active TB in the opinion of the Investigator. Note, the Investigator is permitted, but not required, to incorporate a radiologist's interpretation into their assessment of a participant's chest radiograph.
✓. Confirmation of Mtb infection: Mtb positivity on a molecular test (eg, Xpert Ultra, Hain LPA) conducted on a screening sputum specimen.
✓. Evidence of non-paucibacillary disease: ≥1+ sputum smear positivity for acid-fast bacilli using fluorescent microscopy, as defined on the IUATLD/WHO scale, OR Xpert Ultra semi-quantitative result of 'medium' or 'high' on the sputum specimen for trial screening.

What they're measuring

Stage 1: Percentage of participants with DS-TB reporting severe Adverse events (AEs) (≥ Grade 3) and/or Serious adverse events (SAEs), by treatment group

Timeframe: Up to Week 19 for DBOS and PBOS; up to Week 28 for 2HRZE/4HR

Stage 1: Percentage of participants with pulmonary DS-TB with unfavorable outcome, by treatment group

Timeframe: At Week 17 for DBOS and PBOS; at Week 26 for 2HRZE/4HR

Stage 2: Percentage of participants with DS-TB reporting severe AEs (≥ Grade 3) and/or SAEs, by treatment group

Timeframe: Up to Week 19 for XBOS treatment groups; up to Week 28 for 2HRZE/4HR

Stage 2: Percentage of participants with pulmonary DS-TB reporting unfavorable outcome, by treatment group

Timeframe: At 12 months post-randomization

Trial details

NCT IDNCT05971602

SponsorGates Medical Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-06

View on ClinicalTrials.gov More Pulmonary Tuberculosis trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmation of Mtb infection: Mtb positivity on a molecular test (eg, Xpert Ultra, Hain Line probe assay \[LPA\]) conducted on a sputum specimen for trial screening.
✓. Evidence of non-paucibacillary disease: ≥1+ sputum smear positivity for acid-fast bacilli using fluorescent microscopy, as defined by the International Union Against Tuberculosis and Lung Disease (IUATLD)/World Health Organization (WHO) scale, OR a Xpert Ultra semi-quantitative result of 'medium' or 'high' on the sputum specimen for trial screening.
✓. Drug-susceptible TB: Isoniazid and rifampicin resistance not detected, as determined by a molecular test (eg, Hain LPA, Xpert Ultra, Xpert MTB/Extensively Drug Resistant \[XDR\]) conducted on a sputum specimen for trial screening.
✓. Clinical signs and/or symptoms consistent with active TB in the opinion of the Investigator.
✓. Chest radiograph consistent with active TB in the opinion of the Investigator. Note, the Investigator is permitted, but not required, to incorporate a radiologist's interpretation into their assessment of a participant's chest radiograph.
✓. Confirmation of Mtb infection: Mtb positivity on a molecular test (eg, Xpert Ultra, Hain LPA) conducted on a screening sputum specimen.
✓. Evidence of non-paucibacillary disease: ≥1+ sputum smear positivity for acid-fast bacilli using fluorescent microscopy, as defined on the IUATLD/WHO scale, OR Xpert Ultra semi-quantitative result of 'medium' or 'high' on the sputum specimen for trial screening.

What they're measuring

Stage 1: Percentage of participants with DS-TB reporting severe Adverse events (AEs) (≥ Grade 3) and/or Serious adverse events (SAEs), by treatment group

Timeframe: Up to Week 19 for DBOS and PBOS; up to Week 28 for 2HRZE/4HR

Stage 1: Percentage of participants with pulmonary DS-TB with unfavorable outcome, by treatment group

Timeframe: At Week 17 for DBOS and PBOS; at Week 26 for 2HRZE/4HR

Stage 2: Percentage of participants with DS-TB reporting severe AEs (≥ Grade 3) and/or SAEs, by treatment group

Timeframe: Up to Week 19 for XBOS treatment groups; up to Week 28 for 2HRZE/4HR

Stage 2: Percentage of participants with pulmonary DS-TB reporting unfavorable outcome, by treatment group

Timeframe: At 12 months post-randomization

Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria