Trial Outcomes & Findings for Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2) (NCT NCT05406479)
NCT ID: NCT05406479
Last Updated: 2024-08-28
Results Overview
Mean difference in QTc interval between the two arms 24 hours after treatment administration. Difference (BE-PEP - SDR-PEP)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
313 participants
Primary outcome timeframe
24 hours after treatment administration
Results posted on
2024-08-28
Participant Flow
Participant milestones
| Measure |
BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
Eligible participants will receive one dose of Bedaquiline plus Rifampicin
BE-PEP (Bedaquiline): Single dose of Bedaquiline
BE-PEP (Rifampicine): Single dose of Rifampicin
|
SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
Eligible participants will receive one dose of Rifampicin (WHO recommendation)
SDR-PEP: Single dose of Rifampicin
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
156
|
|
Overall Study
COMPLETED
|
156
|
154
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
n=157 Participants
Eligible participants will receive one dose of Bedaquiline plus Rifampicin
BE-PEP (Bedaquiline): Single dose of Bedaquiline
BE-PEP (Rifampicine): Single dose of Rifampicin
|
SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
n=156 Participants
Eligible participants will receive one dose of Rifampicin (WHO recommendation)
SDR-PEP: Single dose of Rifampicin
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
64 Participants
n=157 Participants
|
62 Participants
n=156 Participants
|
126 Participants
n=313 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=157 Participants
|
94 Participants
n=156 Participants
|
187 Participants
n=313 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=157 Participants
|
0 Participants
n=156 Participants
|
0 Participants
n=313 Participants
|
|
Age, Continuous
|
40 years
n=157 Participants
|
41 years
n=156 Participants
|
41 years
n=313 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=157 Participants
|
83 Participants
n=156 Participants
|
167 Participants
n=313 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=157 Participants
|
73 Participants
n=156 Participants
|
146 Participants
n=313 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Comoros
|
157 Participants
n=157 Participants
|
156 Participants
n=156 Participants
|
313 Participants
n=313 Participants
|
PRIMARY outcome
Timeframe: 24 hours after treatment administrationPopulation: participants included per protocol
Mean difference in QTc interval between the two arms 24 hours after treatment administration. Difference (BE-PEP - SDR-PEP)
Outcome measures
| Measure |
BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
n=150 Participants
Participants received bedaquiline and rifampicine as PEP treatment
|
SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
n=146 Participants
Participants received rifampicine as PEP treatment
|
|---|---|---|
|
Mean Difference in QTc Interval Between the Two Arms 24 Hours After Treatment Administration
Adults (> 18)
|
396.81 msec
Interval 392.45 to 401.17
|
397 msec
Interval 392.94 to 401.06
|
|
Mean Difference in QTc Interval Between the Two Arms 24 Hours After Treatment Administration
Adolescents (13 - 17)
|
404.61 msec
Interval 395.43 to 413.79
|
394.06 msec
Interval 386.33 to 401.79
|
|
Mean Difference in QTc Interval Between the Two Arms 24 Hours After Treatment Administration
Children (5 - 12)
|
391.15 msec
Interval 386.36 to 395.94
|
389.07 msec
Interval 384.52 to 393.62
|
PRIMARY outcome
Timeframe: Until day 30 after treatment administrationPopulation: included in per protocol
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
Outcome measures
| Measure |
BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
n=157 Participants
Participants received bedaquiline and rifampicine as PEP treatment
|
SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
n=156 Participants
Participants received rifampicine as PEP treatment
|
|---|---|---|
|
Occurence of Any Predetermined Study Stopping Criteria, Which Will Trigger an Immediate Pause on Enrollment
Adults (> 18)
|
0 Participants
|
0 Participants
|
|
Occurence of Any Predetermined Study Stopping Criteria, Which Will Trigger an Immediate Pause on Enrollment
Adolescents (13 - 17)
|
0 Participants
|
0 Participants
|
|
Occurence of Any Predetermined Study Stopping Criteria, Which Will Trigger an Immediate Pause on Enrollment
Children (5 - 12)
|
0 Participants
|
0 Participants
|
Adverse Events
BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
n=157 participants at risk
Eligible participants will receive one dose of Bedaquiline plus Rifampicin
BE-PEP (Bedaquiline): Single dose of Bedaquiline
BE-PEP (Rifampicine): Single dose of Rifampicin
|
SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
n=156 participants at risk
Eligible participants will receive one dose of Rifampicin (WHO recommendation)
SDR-PEP: Single dose of Rifampicin
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.64%
1/156 • Number of events 1 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.64%
1/157 • Number of events 1 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.00%
0/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
Other adverse events
| Measure |
BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
n=157 participants at risk
Eligible participants will receive one dose of Bedaquiline plus Rifampicin
BE-PEP (Bedaquiline): Single dose of Bedaquiline
BE-PEP (Rifampicine): Single dose of Rifampicin
|
SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
n=156 participants at risk
Eligible participants will receive one dose of Rifampicin (WHO recommendation)
SDR-PEP: Single dose of Rifampicin
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
2.5%
4/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.64%
1/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Ear and labyrinth disorders
Vertigo
|
8.9%
14/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
6.4%
10/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.00%
0/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.64%
1/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.00%
0/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
7/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.64%
1/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Gastrointestinal disorders
Nausea
|
8.3%
13/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
2.6%
4/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
1.3%
2/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
General disorders
Chest pain
|
0.00%
0/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.64%
1/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
General disorders
malaise
|
0.64%
1/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.00%
0/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
General disorders
pyrexia
|
1.3%
2/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.00%
0/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
14/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
14.1%
22/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Investigations
Aspartate aminotransferase increased
|
14.0%
22/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
13.5%
21/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.64%
1/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.00%
0/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Nervous system disorders
Headache
|
10.8%
17/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
1.3%
2/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Nervous system disorders
Tremor
|
0.64%
1/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.00%
0/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.64%
1/157 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
0.00%
0/156 • Adverse events were collected between administration of the medication (day 1 of the study) until 30 days post administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place