Phase 3
Completed N=511
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
Source: ClinicalTrials.gov NCT01424670 ↗Enrolled (actual)
511
Serious AEs
26.6%
Results posted
May 2019
Primary outcomePrimary: Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System — 51; 57 Days — p=0.0562
◆ Published Evidence
Highly cited
164citations · ~23 / year
Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial.
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.
Linked Publications
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Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System |
51; 57 | 0.0562 |
| SECONDARY Proportion of Participants With SCC At 2 And 6 Months Using MGIT |
132; 54; 198; 87 | 0.3818 |
| SECONDARY Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT |
180; 83; 178; 82; 173; 78 | 0.5945 |
| SECONDARY Treatment Outcomes Assessed By Principal Investigators (PI)At The End Of Treatment With OBR |
182; 85; 42; 16; 2; 0 | 0.5269 |
| SECONDARY Number of Participants Who Developed Resistance To Delamanid |
3; 0 | — |
| SECONDARY Mean (Time Averaged) Area Under The Curve (AUC) Of Change From Baseline In Time To Detection (TTD) To Month 6 Using MGIT |
21.9; 23.3 | 0.6986 |
| SECONDARY Mean Change From Baseline In TTD Using The MGIT System |
16.7; 15.4; 20.8; 19.9; 4.3; 4.8 | 0.6825 |
| SECONDARY Proportion of Participants With Final Outcome At Month 30 As A Treatment Success Or Failure (Including Relapse) Using MGIT |
173; 78; 53; 23 | 0.8951 |
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).
Data sourced from ClinicalTrials.gov (NCT01424670) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.