Leprosy Clinical Trial
— BE-PEOPLE P2Official title:
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 2 Study
Verified date | June 2023 |
Source | Institute of Tropical Medicine, Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022. This new trial will be called the 'Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy' or 'BE-PEOPLE' trial. There will be two main study arms, a comparator arm based on the current WHO recommendation of providing a single dose of rifampicin (10 mg/kg) to close contacts of leprosy patients and an intervention arm in which this regimen will be reinforced with bedaquiline, 400 or 800 mg depending on weight, to be repeated once after four weeks for household contacts. The main study will be preceded by a phase 2 safety study.
Status | Completed |
Enrollment | 321 |
Est. completion date | January 26, 2023 |
Est. primary completion date | January 26, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years and older |
Eligibility | Inclusion Criteria: 1. Being a permanent resident of the study village, in good state of health 2. Able and willing to provide informed consent 3. Age 5 years or above and weight of 20 kg or above Exclusion Criteria: 1. Signs of active leprosy 2. Signs of active pulmonary tuberculosis (cough =2 weeks duration) 3. Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge) 4. History of liver- or kidney disease 5. Allergy to rifampicin or bedaquiline 6. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period 7. Not able to swallow bedaquiline 100 mg tablets 8. Self-reported (suspected) pregnancy or breastfeeding 9. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only) 10. QT-prolongation of =450 msec in baseline ECG within the last week. 11. Jaundice or self-reported liver function abnormalities or hepatitis 12. Value of baseline ALT or AST >3x ULN within the last week. In case only ALT is available, this would suffice for enrollment |
Country | Name | City | State |
---|---|---|---|
Comoros | Fondation Damien | Gege | Anjouan |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium | Damien Foundation |
Comoros,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean difference in QTc interval between the two arms 24 hours after treatment administration | Mean difference in QTc interval between the two arms 24 hours after treatment administration | 24 hours after treatment administration | |
Primary | Occurence of any predetermined study stopping criteria, which will trigger an immediate pause on enrollment | Occurence of any of the following predetermined study stopping criteria, which will trigger an immediate pause on enrollment:
Death of a participant considered related to study drug One or more participants experience an Serious Adverse Event (SAE) or Grade 4 Adverse Event (AE) or a persistent (upon repeat testing) Grade 4 laboratory abnormality that is determined to be related to study drug Three or more participants experience a Grade 3 or greater AE of the same type (as per medical judgement) that is determined to be related to study drug Three or more participants experience a persistent (upon repeat testing) Grade 3 laboratory abnormality related to the same laboratory parameter and considered to be related to study drug Two or more participants experience QTc > 500 ms One or more participants has Aspartate transaminase (AST) or Alanine transaminase (ALT) > 8x Upper limit of normal (ULN), in absence of causative explanation |
Until day 30 after treatment administration | |
Secondary | Baseline frequency of ALT in the population | To determine the baseline frequency of ALT in the population. | At baseline | |
Secondary | Baseline frequency of AST elevations in the population | To determine baseline frequency of AST elevations in the population | At baseline | |
Secondary | Baseline frequency of QTc prolongations in the population | To determine baseline frequency of QTc prolongations in the population | At baseline | |
Secondary | Post administration QTc prolongation | Post administration QTc prolongation | 24 hours after treatment administration | |
Secondary | Post-administration ALT level | Post administration ALT level | Day 14 after treatment administration | |
Secondary | Post-administration AST level | Post-administration AST level | Day 14 after treatment administration | |
Secondary | Frequency of potentially common adverse events such as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions | Frequency of potentially common adverse events such as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions | Until day 30 after treatment administration | |
Secondary | Occurrence of any (serious)AEs | Occurrence of any (serious)AEs | Until day 30 after treatment administration |
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