Status:
COMPLETED
Timing of Surgical Intervention in Buruli Ulcer Patients Treated With Antibiotics
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
PNLUB, Ministère de la santé, Cotonou, République du Bénin.
Laboratoire de Référence des Mycobactéries
Conditions:
Mycobacterium Ulcerans Disease
Buruli Ulcer
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
SUMMARY Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic in West Africa. It often leads to functional limitations. Treatment was by extensive surgery, until...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01432925
Start Date
September 1 2011
End Date
December 1 2016
Last Update
July 22 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Buruli ulcer center Allada
Allada, Benin
2
Buruli ulcer center Lalo
Lalo, Benin