Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin (NCT02975570) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin
Stopped: The study could not be conducted since funding was not obtained.
0Started 2017-08
Plain-language summary
The proposed study will randomize adults (18 years of age or older) with pulmonary MDR-TB with sputum that contains M. tuberculosis that is isoniazid and rifampin resistant by MTBDRplus and fluoroquinolone susceptible by MTBDRsl HIV seropositive (with or without antiretroviral therapy) or negative (but not unknown) and Karnofsky score of \>60 at sites in Moldova, Peru, and the Philippines.
Patients with MDR-TB will be randomized to oral regimen of delamanid (DLM), linezolid (LZD), levofloxacin (LFX) and pyrazinamide (PZA) for 24, 32, 40, 48 or 56 weeks or World Health Organization (WHO) standard of care MDR-TB regimen (9-month "modified Bangladesh" regimen or WHO standard MDR-TB regimen).
Primary Objective
1\. Determine the shortest duration of the delamanid-containing oral regimen that is non-inferior to the blended WHO standard regimen.
Secondary Objective
1. Define the safety and tolerability of the oral delamanid, linezolid, levofloxacin and pyrazinamide regimen.
2. Determine if baseline PZA susceptibility is associated with shorter time to non-inferior treatment duration.
3. Identify the relationship between delamanid and linezolid serum drug levels and time to sputum culture conversion among patients on the delamanid-containing oral regimen.
4. Identify the relationship between delamanid and linezolid serum drug levels and occurrence of adverse events among patients on the delamanid-containing oral regimen.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women age ≥18 years
✓. Subject has pulmonary TB
✓. Sputum Smear, culture or Xpert MTB/RIF assay positive, with Hain MTBDRplus showing Rifampin (RIF) resistance and Isoniazid (INH) resistance and Hain MTBDRsl showing Fluoroquinolone susceptibility.
✓. Patients within two weeks (≤14 days) of starting second-line anti-TB drugs
✓. HIV seropositive or seronegative but not unknown HIV serostatus. If the last documented negative HIV test was more than 3 months prior to randomization the current serostatus must be assessed.
✓. Karnofsky score of \> 60 (see Appendix B) at screening and randomization
✓. Willingness by the patient to attend scheduled follow-up visits and undergo study assessments.
✓. Women with child-bearing potential must agree to practice an adequate birth control or to abstain from heterosexual intercourse during study regimen.
Exclusion criteria
✕
What they're measuring
1
Successful outcome at 18 months after randomization using culture results, follow up visits,