CompletedPhase 3

A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB

South Africa109 participantsStarted 2015-03

Plain-language summary

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture positive at month 4) in participants with either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or non-responsive multi-drug resistant tuberculosis (MDR-TB).

Who can participate

Age range14 Years

SexALL

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Inclusion criteria

✓. Provide written, informed consent prior to all trial-related procedures (if under 18, include consent of legal guardian).
✓. Body weight of ≥35 kg (in light clothing and no shoes).
✓. Male or female, aged 14 years or above.
✓. Subjects with one of the following pulmonary TB conditions (WHO definitions prior to 2021):

Exclusion criteria

✕. Karnofsky score \< 50 within 30 days prior to entry.
✕. Body Mass index (BMI) \< 17 kg/m²
✕. History of allergy or known hypersensitivity to any of the trial Investigational Medicinal Products or related substances.
✕. HIV infected Subjects having a CD4+ count ≤ 50 cells/μL
✕. Having participated in other clinical studies with dosing of investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational study that includes treatment with medicinal agents. Subjects who are participating in observational studies or who are in a follow up period of a trial that included drug therapy may be considered for inclusion.
✕. Significant cardiac arrhythmia requiring medication.
✕. Subjects with the following at Screening:
✕. QTcF interval on ECG \>500 msec.

What they're measuring

Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 6 Months After the End of Treatment.

Timeframe: 6 Months post End of Treatment

Trial details

NCT IDNCT02333799

SponsorGlobal Alliance for TB Drug Development

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-14

Results submitted2023-01-23

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