A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
Condition: Tuberculosis, Pulmonary; Tuberculosis, Multidrug Resistant; Extensively Drug-Resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of
      multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background
      regimen (OBR), participants will be randomized to receive:

        -  100 mg OPC-67683 twice daily (BID)

        -  200 mg OPC-67683 BID

        -  Placebo BID

      After 56 days participants will complete their optimized background regimen (OBR).
    

Detailed description: 
      This is a multi center, randomized, double-blinded, stratified, placebo-controlled clinical
      trial in three parallel groups. Participants will be randomized to one of the following three
      treatment groups:

        -  OBR plus 100 mg OPC-67683 BID

        -  OBR plus 200 mg OPC-67683 BID

        -  OBR plus placebo BID

      The three treatment groups will comprise approximately 140 participants each (male or
      female). The trial will consist of the following periods:

        -  Pre-treatment Period (Visits 1 to 3 [Day -9 to Day -1])

        -  Treatment Period (Visits 4 to 59 [Days 1 to 56])

        -  Post-treatment Period (Visits 60 to 64 [Days 57 to 84])

      Enrolled participants (those accepted into the screening period of the trial who signed an
      informed consent form) will be stratified at randomization by extent of pulmonary TB; an
      equal number of participants with and without cavities visible in the lung fields on baseline
      chest radiograph will be allocated to each treatment group. A total of approximately 430 male
      or female participants aged 18 to 64 years, inclusive, with pulmonary, sputum
      culture-positive MDR TB (TB caused by Mycobacterium tuberculosis strains resistant to at
      least isoniazid and rifampicin) or with sputum smears positive for acid fast bacilli (AFB)
      and a positive rapid test for rifampicin resistance on direct sputum within 60 days prior to
      the expected date of enrollment. Participants with positive AFB smears and a positive rapid
      rifampicin resistance test will be enrolled as presumptively culture positive and withdrawn
      as ineligible if they are confirmed to not have sputum culture positive MDR TB.
    

Intervention name(s): Delamanid; Optimized Background Regimen (OBR); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Delamanid was administered orally twice daily as 50-mg tablets under fed conditions in the morning and evening.; Selection and administration of the treatment medications (i.e., OBRs) was based on World Health Organization (WHO's) Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.
Study Investigator could change OBR for a participant based on participant's tolerability and drug susceptibility testing (DST) results.; Placebo tablets matching 50-mg tablets of delamanid
Other intervention name(s): OPC-67683
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tuberculosis; Pulmonary; Multidrug resistant; Antitubercular Agents; OPC 67683