Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens o… (NCT05971602) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With DS-TB Reporting ≥ Grade 3 Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Timeframe: Two weeks after the end of treatment [19 weeks for Arm 1 (DBOS) and Arm 2 (PBOS), and 28 weeks for Arm 3 (HRZE)]
2
Percentage of Participants With Pulmonary DS-TB With Unfavorable Outcome Status
Timeframe: Through Week 17 post-randomization for Arm 1 (DBOS) and Arm 2 (PBOS), and Week 26 post-randomization for Arm 3 (HRZE)
. 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.
. Resistance pattern:
Exclusion criteria
. Not on antiretroviral treatment at time of screening or taking antiretroviral treatment for \<3 months prior to screening, OR
. Cluster of differentiation (CD)4+ T-cell count \<200 cells/microliter (μL) during the screening period, OR
. HIV viral load \>200 copies/milliliter (mL) during the screening period, OR
. Evidence of a currently active opportunistic malignancy or infection related to HIV other than TB that requires treatment with a prohibited concomitant medication (oral candidiasis is not exclusionary) OR
. HIV-infected participants enrolling at a trial site in Peru will not be eligible due to the requirement for longer TB treatment courses than the standard 6-month HRZE regimen for patients with HIV/TB co-infection as per the Peruvian national TB treatment guidelines.
. Estimated creatinine clearance \<60 mL/minute
. Alanine transaminase (ALT) or aspartate transaminase (AST) \>2.5 × upper limit of normal of the clinical laboratory reference range
. Total bilirubin \>2x upper limit of normal of the clinical laboratory reference range, at screening