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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01432925 |
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Date of registration:
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08/09/2011 |
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Primary sponsor: |
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Public title:
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Timing of Surgical Intervention in Buruli Ulcer Patients Treated With Antibiotics
Burulitime |
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Scientific title:
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Timing of the Decision on Surgical Intervention for Buruli Ulcer Patients Treated With Rifampicin/Streptomycin |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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260 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01432925 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Benin
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Contacts
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Name:
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Ymkje Stienstra, MD PhD |
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Address:
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Telephone:
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+31-50-3616161 |
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Email:
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y.stienstra@umcg.nl |
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Affiliation:
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Name:
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R OC Johnson, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cotonou, Bénin |
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Name:
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G Sopoh, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Program national lutte contre la lèpre et l'ulcère de Buruli, Ministère de la Santé, Cotonou, Bénin, hospital Allada |
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Name:
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D Agossadou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Program national lutte contre la lèpre et l'ulcère de Buruli, ministère de la santé, Hospital Lalo |
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Name:
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Tjip S van der Werf, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UMCG - internal medicine/infectious diseases |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a clinical picture of Buruli ulcer disease in the districts covered by
the Buruli ulcer centers in Lalo and Allada, Benin, will be included at start of
antibiotic treatment.
- All stages of the disease will be included. Only patients with confirmed disease by
direct microscopy following acid-fast staining or PCR will be included.
Exclusion Criteria:
- Patients not on the standard treatment of eight weeks of rifampicin and streptomycin
for any reason, will be excluded from this study.
- Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or
immune-modulatory drugs including corticosteroids within the previous one month.
- Patients not compliant with the antibiotic therapy will be excluded as well.
Non-compliance is defined as the use of < 70 % of the prescribed antibiotics.
- Patients with a contraindication for general anaesthesia are not able to participate.
- Pregnancy.
- Osteomyelitis.
- Lesion close to the eye, with preferred standard treatment to wait for effect
antibiotic treatment on extent surgery.
- The BUFLS (Buruli ulcer functional limitation score) cannot be applied to children
below three years and therefore will not participate.
- Patients reporting to refuse surgery at any point in the intended treatment, cannot
be included.
- Any situation or condition which may compromise ability to comply with the trial
procedures.
- Patients known to be HIV positive.
- Lack of willingness to give informed consent (and/or assent by parent/legal
representative).
Age minimum:
3 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Buruli Ulcer
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Mycobacterium Ulcerans Disease
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Intervention(s)
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Procedure: surgical intervention on Buruli ulcer
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Primary Outcome(s)
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Healing without surgical intervention
[Time Frame: one year]
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Secondary ID(s)
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BURULIVENI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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