Phase 2
Completed N=214
Treatment Shortening of MDR-TB Using Existing and New Drugs
Tuberculosis, Multidrug-Resistant
Source: ClinicalTrials.gov NCT02619994 ↗
Enrolled (actual)
214
Serious AEs
23.2%
Results posted
Jan 2025
Primary outcomePrimary: Treatment Success Rate — 60; 54 Participants
Summary
The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen including injectables for 20 to 24 months (control arm)' for treating fluoroquinolone-sensitive multidrug-resistant tuberculosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success Rate |
60; 54 | — |
| SECONDARY Time to Sputum Culture Conversion After Treatment Start |
24; 27 | — |
| SECONDARY Sputum Culture Conversion Proportion |
45; 39 | — |
| SECONDARY Treatment Success at the End of Treatment |
64; 61 | — |
| SECONDARY Proportion of Reverting to Positive Sputum Culture After the End of Treatment |
0; 1 | — |
| SECONDARY Treatment Success According to Pyrazinamide Resistance (1) |
13; 19 | — |
| SECONDARY Proportion of Death Between the Control and Investigational Arms |
2; 5 | — |
| SECONDARY Treatment Success According to Pyrazinamide Resistance (2) |
41; 32 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females aged from 19 to 85 years
- Confirmed MDR-TB or RR-TB
- On current TB therapy for ≤14 days at the time of enrollment.
Exclusion Criteria
- Known any quinolone-resistant MDR-TB
- Known XDR-TB
- who are pregnant or who are unwilling to use proper contraceptives at childbearing age
- Medical history of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- The need for ongoing use of prohibited drugs while on study drugs
- History of optic neuropathy or peripheral neuropathy
- With any of the following test results: i.Absolute neutrophil count 2.0 mg/dL, v.Aspartate aminotransferase (AST or SGOT) >100 IU/L, vi.Alanine aminotransferase (ALT or SGPT) >100 IU/L, vii.Total bilirubin > 2.0 mg/dL, viii.Albumin 500ms
- History of hypersensitivity reaction to the study drugs
Data sourced from ClinicalTrials.gov (NCT02619994). 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.