CLINICAL TRIAL

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Status: Enrolling

Prospective, Duration-Randomized, Partially Blinded, Phase 2 Study of the Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients with MDR-TB

Short Title/Acronym: DRAMATIC Trial

Description:

DRAMATIC (Duration Randomized Anti-MDR-TB And Tailored Intervention Clinical) Trial is a multicenter, randomized, partially blinded, four-arm, phase 2 trial that will examine an injectable- and pyrazinamide-sparing regimen of bedaquiline, delamanid, levofloxacin, linezolid, and clofazimine for treatment of MDR-TB. Participants will be randomized (1:1:1:1) to the following four investigational arms. All arms receive the same investigational oral regimen of levofloxacin, bedaquiline, linezolid, delamanid, and clofazimine; each arm represents a different the total duration of treatment, specifically 16 weeks (112 doses), 24 weeks (168 doses), 32 weeks (224 doses) or 40 weeks (280 doses).

Start Date: May 19, 2019

Eligibility:

  • The proposed study will randomize 220 participants, including adults (18 years of age or older) and children (12-17 years of age)
  • Have pulmonary MDR-TB with sputum that contains M. tuberculosis that is rifampin-resistant and fluoroquinolone-susceptible by a validated molecular test
  • Are HIV seropositive (with or without baseline antiretroviral therapy) or negative (but not unknown)
  • To Participate in the study kindly reach us via:

     socialworkers@tbhivicr.org.ph
     Call or Text for Smart: 09087751951
     Call or Text for Globe: 09958492471