Buruli ulcer
Conditions
Interventions
Standard RC8
Investigational RCA4
Sponsors
University of Zaragoza
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - All patients (both genders) with a new “Very Likely” or “Likely” (as per World Health Organisation, WHO, scoring criteria) clinical BU diagnosis (all categories: I, II, III).(The WHO clinical diagnosis would be supported, as agreed, by the trial and reviewed by the local study technical expert panel.) - Normal ECG (QTc = 450 ms) at baseline that give informed consent will be included in the study.
Exclusion criteria
Exclusion criteria: • Children 70 years. • Children in foster care. • Patients weighing less than 11 kilograms. • Pregnancy positive (urine test: beta-HCG positive). • Previous treatment of BU with at least one of the study drugs within 1 year before recruitment. • Patients with diagnosis of leprosy or tuberculosis disease. • Hypersensitivity to at least one of the study drugs or to any of the excipients. • History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to amoxicillin or another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). • History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid or rifampicin. • Patients with history of treatment with macrolide or quinolone antibiotics, anti-tuberculosis medication, or immuno-modulatory drugs including corticosteroids within one month before recruitment. • Patients currently receiving treatment with any drug likely to interact with the study medications, i.e. anticoagulants, cyclosporine, phenytoin or phenobarbitone. Users of oral contraceptives should be notified that such contraceptive is less reliable if taken with rifampicin; additional (mechanical) contraceptive methods will be discussed with the study participant (Appendix 5). • Patients with HIV co-infection. • Patients with QTc prolongation >450 ms on ECG or taking other medication known to prolong the QTc interval, such as quinolones. In this case, if suspected of BU disease, patients will be treated according to established local guidelines, i.e. with rifampicin and streptomycin for 8 weeks, if available, or will be referred for surgical treatment. • Patients unable to take oral medications or having gastrointestinal disease likely to interfere with drug absorption. • Patients with history or having current clinical signs of ascites, jaundice, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and severe immune compromise, or evidence of tuberculosis, or leprosy; terminal i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate, i.e., proportion of patients with complete lesion healing without recurrence and without excision surgery 12 months after treatment initiation, in the Per Protocol (PP) PCR-positive population. The PP PCR-positive population includes those randomized patients with a WHO clinical diagnosis of “Very Likely BU” or “Likely BU”, PCR-positive and with no major violations of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complete lesion healing without recurrence and without excision surgery, 12 months after start of treatment in the ITT-E PCR-positive, PP CD, and ITT-E CD populations. - Intention To Treat Exposed (ITT-E) PCR-positive population. The ITT-E PCR-positive population includes those randomized patients with a clinical diagnosis of “Very Likely BU” or “Likely BU”, PCR-positive that have, at least, taken one dose of the study drugs. This population might include major violators of the protocol. - Per Protocol (PP) Clinical Diagnose (CD) population. The PP CD population includes those randomized patients with a clinical diagnosis of “Very Likely BU” or “Likely BU” and with no major violations of the protocol. This population includes both PCR-positive and PCR-negative. - Intention To Treat Exposed (ITT-E) Clinical Diagnose (CD) population. The ITT-E CD population includes those randomized patients with a clinical diagnosis of “Very Likely BU” or “Likely BU” that have, at least, taken one dose of the study drugs. This population might include both PCR-positive and PCR-negative and major violators of the protocol. ;Rate of complete lesion healing without recurrence and without excision surgery 12 months after start of treatment by category (I, II & III) lesions analysis in all ITT-E and PP populations. - Intention-to-Treat Exposed (ITT-E) population. This population will consist of all randomized patients, with a clinical diagnosis of “Very Likely BU” or “Likely BU” (WHO), who receive at least one dose of randomized study medication. Patients will be assessed according to their randomized treatment, regardless of the treatment they receive. - Per Protocol (PP) population.This population will consist of subjects | — |
Countries
Benin, Cote Divoire, Togo
Contacts
Public ContactSantiago Ramon Garcia
Investigator ARAID University of Zaragoza
Outcome results
None listed