LeprosyPhase 2BE-PEOPLE P2NCT05406479
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)
A Phase 2 study testing BE-PEP (Bedaquiline), SDR-PEP and BE-PEP (Rifampicine) in people with Leprosy, run by Institute of Tropical Medicine, Belgium at 1 site in Comoros.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leprosy
- What is being tested?
- BE-PEP (Bedaquiline), SDR-PEP and BE-PEP (Rifampicine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteComoros
- Study dates
- 14 Jul 2022to 26 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a permanent resident of the study village, in good state of health
- Able and willing to provide informed consent
- Age 5 years or above and weight of 20 kg or above
Who cannot join
- Signs of active leprosy
- Signs of active pulmonary tuberculosis (cough ≥2 weeks duration)
- Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
- History of liver- or kidney disease
- Allergy to rifampicin or bedaquiline
- Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
Show all 12Show fewer
- Not able to swallow bedaquiline 100 mg tablets
- Self-reported (suspected) pregnancy or breastfeeding
- Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)
- QT-prolongation of ≥450 msec in baseline ECG within the last week.
- Jaundice or self-reported liver function abnormalities or hepatitis
- Value of baseline ALT or AST >3x ULN within the last week. In case only ALT is available, this would suffice for enrollment
Trial locations and contacts
1 site in 1 country.
Comoros1 site
Fondation Damien
Gege, Anjouan
About this study
Official title: Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 2 Study
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.
Read the detailed description
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.
- Conditions
- Leprosy
- Being tested
- BE-PEP (Bedaquiline), SDR-PEP, BE-PEP (Rifampicine)
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BE-PEP (Bedaquiline)Drug
Single dose of Bedaquiline
SDR-PEPDrug
Single dose of Rifampicin
BE-PEP (Rifampicine)Drug
Single dose of Rifampicin
| Study group | Role | What they receive |
|---|---|---|
| BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | Experimental | Eligible participants will receive one dose of Bedaquiline plus Rifampicin Receives: Drug: BE-PEP (Bedaquiline); Drug: BE-PEP (Rifampicine) |
| SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) | Active comparator | Eligible participants will receive one dose of Rifampicin (WHO recommendation) Receives: Drug: SDR-PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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:
- 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
Measured: Until day 30 after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start14 Jul 2022
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Damien Foundation
- Responsible party
- Sponsor
- Investigators
- Younoussa Assoumani, Principal investigator, Damien Foundation Comoros
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406479
- Sponsor's protocol ID
- BE-PEOPLE Phase 2
- Acronym
- BE-PEOPLE P2
- Status last verified
- Aug 2024
- First submitted
- 20 May 2022
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Jong BC, Nourdine S, Bergeman AT, Salim Z, Grillone SH, Braet SM, Wirdane Abdou M, Snijders R, Ronse M, Hoof C, Tsoumanis A, Ortuno-Gutierrez N, der Werf CV, Piubello A, Mzembaba A, Assoumani Y, Hasker E. Safety of single-dose bedaquiline combined with rifampicin for leprosy post-exposure prophylaxis: A Phase 2 randomized non-inferiority trial in the Comoros Islands. PLoS Med. 2024 Oct 21;21(10):e1004453. doi: 10.1371/journal.pmed.1004453. eCollection 2024 Oct.
PubMed 39432509
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 2 Study
- ClinicalTrials.gov ID
- NCT05406479
- Acronym / sponsor ID
- BE-PEOPLE P2 / BE-PEOPLE Phase 2
- Conditions
- Leprosy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Damien Foundation
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BE-PEP (Bedaquiline Post-Exposure Prophylaxis) | Experimental | Drug: BE-PEP (Bedaquiline), Drug: BE-PEP (Rifampicine)Eligible participants will receive one dose of Bedaquiline plus Rifampicin |
| SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) | Active comparator | Drug: SDR-PEPEligible participants will receive one dose of Rifampicin (WHO recommendation) |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being a permanent resident of the study village, in good state of health
- Able and willing to provide informed consent
- Age 5 years or above and weight of 20 kg or above
Key exclusion criteria (12 listed)
- Signs of active leprosy
- Signs of active pulmonary tuberculosis (cough ≥2 weeks duration)
- Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
- History of liver- or kidney disease
- Allergy to rifampicin or bedaquiline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BE-PEP (Bedaquiline)Single dose of Bedaquiline | Drug | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) |
| SDR-PEPSingle dose of Rifampicin | Drug | SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis) |
| BE-PEP (Rifampicine)Single dose of Rifampicin | Drug | BE-PEP (Bedaquiline Post-Exposure Prophylaxis) |
Primary outcome
Mean Difference in QTc Interval Between the Two Arms 24 Hours After Treatment Administration
Time frame: 24 hours after treatment administration
Mean difference in QTc interval between the two arms 24 hours after treatment administration. Difference (BE-PEP - SDR-PEP)
Occurence of Any Predetermined Study Stopping Criteria, Which Will Trigger an Immediate Pause on Enrollment
Time frame: Until day 30 after treatment administration
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39432509de Jong BC, Nourdine S, Bergeman AT, Salim Z, Grillone SH, Braet SM, Wirdane Abdou M, Snijders R, Ronse M, Hoof C, Tsoumanis A, Ortuno-Gutierrez N, der Werf CV, Piubello A, Mzembaba A, Assoumani Y, Hasker E. Safety of single-dose bedaquiline combined with rifampicin for leprosy post-exposure prophylaxis: A Phase 2 randomized non-inferiority trial in the Comoros Islands. PLoS Med. 2024 Oct 21;21(10):e1004453. doi: 10.1371/journal.pmed.1004453. eCollection 2024 Oct.
Related trials for Leprosy
RecruitingPhase 2
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
Erythema Nodosum Leprosum
RecruitingObservational study
Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
Atopic Dermatitis, Psoriasis
RecruitingPhase 3
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Leprosy
Recruiting
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
Leprosy, Leprosy Neuropathy
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Younoussa Assoumani principal investigator
Damien Foundation Comoros
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BE-PEP (Bedaquiline), SDR-PEP and BE-PEP (Rifampicine) in people with Leprosy, run by Institute of Tropical Medicine, Belgium at 1 site in Comoros.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Comoros. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in QTc Interval Between the Two Arms 24 Hours After Treatment Administration (time frame: 24 hours after treatment administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.