Phase 3
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 · Extensively Drug-Resistant Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT03086486 ↗Enrolled (actual)
181
Serious AEs
6.1%
Results posted
Jun 2023
Primary outcome: 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 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pretomanid (Drug); Linezolid (Drug); Bedaquiline (Drug); Placebo Linezolid (Drug)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Global Alliance for TB Drug Development
- Primary completion
- Feb 2021
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 | — |
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.
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). 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.