Phase 3
Completed N=181
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
Tuberculosis, Pulmonary · Tuberculosis, Multidrug-Resistant · Tuberculosis, MDR · Tuberculosis
Source: ClinicalTrials.gov NCT03086486 ↗
Enrolled (actual)
181
Serious AEs
6.1%
Results posted
Jun 2023
Primary outcomePrimary: Incidence of Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) Through Follow up Until 26 Weeks After the End of Treatment — 41; 40; 41; 37 Participants
◆ Published Evidence
Highly cited
569citations · ~142 / year
Bedaquiline-Pretomanid-Linezolid Regimens for Drug-Resistant Tuberculosis.
Summary
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment intolerant or non-responsive MDR-TB.
Linked Publications
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Bedaquiline-Pretomanid-Linezolid Regimens for Drug-Resistant Tuberculosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) Through Follow up Until 26 Weeks After the End of Treatment |
41; 40; 41; 37; 159; 3 | — |
| SECONDARY Incidence of Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) Through Follow up Until 78 Weeks After the End of Treatment. |
40; 39; 40; 35; 154; 3 | — |
| SECONDARY Time to Sputum Culture Conversion to Negative Status Through the Treatment Period |
4; 4; 6; 6; 6 | — |
| SECONDARY Sputum Culture Conversion to Negative Status at End of Treatment for Those Positive at Baseline |
29; 28; 31; 31; 119; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 14 years or older.
- One of the following with documentation of culture positive or molecular test within 3 months of screening:
- XDR-TB defined as resistance to rifamycins, a fluoroquinolone AND an injectable OR
- Pre-XDR-TB with defined as resistance to rifamycins, and to a fluoroquinolone OR an injectable OR
- MDR-TB with resistance to rifamycins, and either non-responsive or non-tolerant to current treatment.
- Of non-childbearing potential or willing to practice effective birth control methods.
- Complete informed consent form.
Exclusion criteria
- Karnofsky score 1000 copies/mL (Unless newly diagnosed HIV and not yet on ART who otherwise qualify for participation);
- CD4+ count 3.0 x ULN)
- Total bilirubin greater than 1.5 x ULN
- Direct bilirubin greater than ULN
- Serum creatinine level greater than 1.5 times upper limit of normal
- Albumin <3.0 g/dl or < 30 g/L
Data sourced from ClinicalTrials.gov (NCT03086486) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.