Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin
Status:
Withdrawn
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
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.