A Phase 2 interventional study of BE-PEP (Bedaquiline) and SDR-PEP in Leprosy, sponsored by Institute of Tropical Medicine, Belgium. Completed at 1 site in Comoros. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Institute of Tropical Medicine, Belgium · Phase 2, Interventional, and Prevention
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.
Given the fact that the investigators are going to provide to healthy people a drug that has not been used before for this indication and which has only been conditionally approved for use in multi-drug resistant tuberculosis, they have first foreseen a phase 2 study in which BE-PEP will be provided to a limited number of contacts and in which safety will be closely monitored and evaluated by an independent data and safety monitoring board (DSMB). This will be done in a small village that is part arm 1 of the PEOPLE trial in which 8 new cases have been diagnosed since 2019 but no PEP has been provided. The investigators will conduct door-to-door screening in this village in June 2022 and offer a single dose of BE-PEP to a random sample of 150 people screened aged 5 years and above not meeting the exclusion criteria (active tuberculosis (TB) or leprosy or previously treated leprosy, known liver function or cardiac abnormalities, not able to swallow 100 mg bedaquiline tablets). Participants will be followed up closely with active monitoring for adverse events, including measurement of the corrected QT interval and liver function before and after administration, as well as gastro-intestinal (nausea, vomiting), nervous system-related (headache, dizziness) and cutaneous reactions. The remainder of the population of this village aged two years and above will be offered single dose rifampicin as per WHO recommendations. In a randomly sampled subset of 150 individuals receiving rifampicin only, the same stringent monitoring with ECG and liver function tests also applied in those receiving BE-PEP will be performed.
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's enrollment of 313 is above the median of 70 across 41 interventional studies indexed under Leprosy.
Browse Leprosy studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 104 studies on the registry; 21 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants will receive one dose of Bedaquiline plus Rifampicin
Drug: BE-PEP (Bedaquiline) · Drug: BE-PEP (Rifampicine)
Eligible participants will receive one dose of Rifampicin (WHO recommendation)
Drug: SDR-PEP
Single dose of Bedaquiline
Single dose of Rifampicin
Single dose of Rifampicin
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. Difference (BE-PEP - SDR-PEP)
Time frame: 24 hours after treatment administration
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: 1. Death of a participant considered related to study drug 2. 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 3. 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 4. 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 5. Two or more participants experience QTc \> 500 ms 6. One or more participants has Aspartate transaminase (AST) or Alanine transaminase (ALT) \> 8x Upper limit of normal (ULN), in absence of causative explanation
Time frame: Until day 30 after treatment administration
| Milestone | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) |
|---|---|---|
| Started | 157 | 156 |
| Completed | 156 | 154 |
| Not completed | 1 | 2 |
Mean difference in QTc interval between the two arms 24 hours after treatment administration. Difference (BE-PEP - SDR-PEP)
| msec | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) |
|---|---|---|
| Adults (> 18) | 396.81 (392.45 to 401.17) | 397 (392.94 to 401.06) |
| Adolescents (13 - 17) | 404.61 (395.43 to 413.79) | 394.06 (386.33 to 401.79) |
| Children (5 - 12) | 391.15 (386.36 to 395.94) | 389.07 (384.52 to 393.62) |
Occurence of any of the following predetermined study stopping criteria, which will trigger an immediate pause on enrollment: 1. Death of a participant considered related to study drug 2. 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 3. 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 4. 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 5. Two or more participants experience QTc \> 500 ms 6. One or more participants has Aspartate transaminase (AST) or Alanine transaminase (ALT) \> 8x Upper limit of normal (ULN), in absence of causative explanation
| Participants | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) |
|---|---|---|
| Adults (> 18) | 0 | 0 |
| Adolescents (13 - 17) | 0 | 0 |
| Children (5 - 12) | 0 | 0 |
Collected over Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | 0/157 (0%) | 1/157 (0.6%) | 65/157 (41.4%) |
| SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) | 0/156 (0%) | 1/156 (0.6%) | 50/156 (32.1%) |
| Event | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) |
|---|---|---|
| Diabetic metabolic decompensationMetabolism and nutrition disorders | 0/157 | 1/156 |
| Foetal deathPregnancy, puerperium and perinatal conditions | 1/157 | 0/156 |
| Event | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) |
|---|---|---|
| Alanine aminotransferase increasedInvestigations | 14/157 | 22/156 |
| Aspartate aminotransferase increasedInvestigations | 22/157 | 21/156 |
| HeadacheNervous system disorders | 17/157 | 2/156 |
| VertigoEar and labyrinth disorders | 14/157 | 10/156 |
| NauseaGastrointestinal disorders | 13/157 | 4/156 |
| DiarrhoeaGastrointestinal disorders | 7/157 | 1/156 |
| PalpitationsCardiac disorders | 4/157 | 1/156 |
| VomitingGastrointestinal disorders | 1/157 | 2/156 |
| Abdominal painGastrointestinal disorders | 2/157 | 0/156 |
| pyrexiaGeneral disorders | 2/157 | 0/156 |
All randomized participants
| Age, Categorical(Participants) | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) | Total |
|---|---|---|---|
| <=18 years | 64 | 62 | 126 |
| Between 18 and 65 years | 93 | 94 | 187 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) | Total |
|---|---|---|---|
| Median | 40 (31 to 53) | 41 (32 to 54.5) | 41 (32 to 53) |
| Sex: Female, Male(Participants) | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) | Total |
|---|---|---|---|
| Female | 84 | 83 | 167 |
| Male | 73 | 73 | 146 |
| Race and Ethnicity Not Collected(Participants) | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) | Total |
|---|---|---|---|
| Comoros | 157 | 156 | 313 |
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Studies of the drug tested here: Bedaquiline
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