Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
Condition: Multidrug-resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Intervention: Delamanid + OBR; Placebo + OBR
Intervention description: The assigned doses of delamanid were administered with an OBR. The selection and administration of the OBR were based on WHO's guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.; Matching placebo was administered with an OBR. The selection and administration of the OBR were based on WHO's guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Multidrug-resistant tuberculosis

Summary:

      The purpose of this trial is to determine whether delamanid is effective in the treatment of
      multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during
      6 months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written, informed consent

          -  Current diagnosis of MDR TB

          -  Chest radiograph consistent with TB

          -  Able to produce sputum

          -  Negative urine pregnancy test and agree to use a highly effective method of birth
             control and/or adequate method of contraception

        Exclusion Criteria:

          -  Allergy to any nitro-imidazoles or nitro-imidazole derivates

          -  Diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole
             derivates is contra-indicated

          -  Use of disallowed medications

          -  Renal impairment

          -  Abnormal electrocardiogram (ECG) results

          -  Cardiovascular disorders

          -  Body mass index (BMI) < 16 kg/m^2

          -  Karnofsky score < 50%

          -  Significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine
             diseases, active malignancy

          -  Alcohol abuse

          -  Pregnant, breast-feeding, or planning to conceive or father a child

          -  Recent use of methadone, benzodiazepines, cocaine, amphetamine/methamphetamine,
             tetrahydrocannabinol, barbiturates, and opiates

          -  Previous exposure to delamanid

          -  Administered an investigational medicinal product (IMP) within 1 month prior to
             Screening (Days -21 to -2).

          -  Evidence of extensively drug-resistant TB based on the definition from WHO

          -  Human immunodeficiency virus (HIV) co-infection for participants screened at sites not
             participating in the HIV subtrial (data from the HIV subtrial will be reported
             separately from the Clinical Study Report for Study 242-09-213).