|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01659437 |
|
Date of registration:
|
02/08/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
WHO Drug Study for Buruli Ulcer - Comparison of SR8 and CR8
|
|
Scientific title:
|
Randomized Controlled Trial Comparing Efficacy of 8 Weeks Treatment With Clarithromycin and Rifampicin Versus Streptomycin and Rifampicin for Buruli Ulcer (M. Ulcerans Infection) |
|
Date of first enrolment:
|
December 2012 |
|
Target sample size:
|
310 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01659437 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Benin
|
Ghana
| | | | | | |
|
Contacts
|
|
Name:
|
Richard O Phillips, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science & Technology, Kumasi, Ghana |
|
|
Name:
|
Kingsley B Asiedu, MD, MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
WHO, GBUI, Geneva, Switserland |
|
|
Name:
|
Annick Chauty, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pobè Health Centre, Pobè, Bénin |
|
|
Name:
|
Tjip S van der Werf, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Groningen, University Medical Centre Groningen |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
- All patients (both genders) with a clinical diagnosis of BUD (categories: I and II,
cross-sectional diameter = 10cm) as agreed by study site treatment team led by the
lead clinicians
Exclusion criteria:
1. Patients with lesion sizes >10cm in cross-sectional diameter
2. Children < 5 years, or < 20 kilograms body weight
3. Pregnancy (self-reported, clinically diagnosed, or urine test (beta-hCG) positive
4. Patients with previous treatment of Buruli ulcer, tuberculosis or leprosy with at
least one of the study drugs (rifampicin, streptomycin, clarithromycin)
5. Patients with history of hypersensitivity to rifampicin and/or streptomycin and/or
clarithromycin
6. Patients with previous treatment with macrolide or quinolone antibiotics, or
antituberculosis medication, or immuno-modulatory drugs including corticosteroids
within one month
7. Patients with current treatment with any drugs likely to interact with the study
medication, e.g, anticoagulants, cyclosporin, phenytoin, and phenobarbitone. Users of
oral contraceptives should be notified that such contraceptive is less reliable if
taken with rifampicin; alternative (mechanical) contraceptive methods will be
discussed with the study participant
8. Patients with co-infection with HIV
9. Patients with history or having current clinical signs of ascites, jaundice, partial
or complete deafness, myasthenia gravis, renal dysfunction (known or suspected),
diabetes mellitus, and severe immune compromise (e.g., immunosuppressive drugs after
organ transplant), or evidence of (previous) tuberculosis, Buruli ulcer or leprosy; or
terminal illness (e.g., metastasized cancer)
10. Patients who are unable to take oral medication or having gastrointestinal disease
likely to interfere with drug absorption
11. Patients with known or suspected bowel strictures who cannot tolerate macrolide
antibiotics such as clarithromycin
12. Patients with mental condition, including addiction with substance abuse (alcohol,
qat, etc) likely to interfere with possibility to comply with the study protocol
13. Patients who are not willing to give informed pre-consent, and consent (patient and/or
parent/legal representative), or withdrawal of consent
Age minimum:
5 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Mycobacterium Ulcerans Infection
|
|
Intervention(s)
|
|
Drug: Streptomycin intramuscular injection
|
|
Drug: Clarithromycin Extended Release
|
|
Primary Outcome(s)
|
|
healing without recurrence and without excision surgery
[Time Frame: 12 months after start of treatment]
|
|
Secondary Outcome(s)
|
|
Rate of paradoxical response within 12 months of treatment initiation
[Time Frame: 12 months]
|
|
Recurrence rate within 12 months of treatment initiation
[Time Frame: 12 months]
|
|
Time taken for complete lesion healing within 12 months of treatment initiation
[Time Frame: 12 months]
|
|
Proportion of each type of surgery within 12 months of treatment initiation
[Time Frame: 12 months]
|
|
Interval between healing and recurrence
[Time Frame: 12 months]
|
|
Proportion of patients with reduction in lesion surface area within 12 months of treatment initiation
[Time Frame: 12 months]
|
|
Time from treatment initiation to surgery if any
[Time Frame: 12months]
|
|
Treatment discontinuation and compliance rates
[Time Frame: 8 weeks]
|
|
Incidence of all adverse effects (AEs) within 12 months of treatment initiation
[Time Frame: 12 months]
|
|
Proportion (%) of patients with complete healing without additional surgery or relapse
[Time Frame: 12 months]
|
|
Proportion of patients with residual functional limitations
[Time Frame: 12 months]
|
|
Rate of treatment failure within 12 months of treatment initiation
[Time Frame: 12 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|