Shortening Buruli Ulcer treatment: WHO recommended vs. a novel beta-lactam-containing therapy - Phase III evaluation in West Africa

Phase 3

• Conditions: Buruli ulcer

• Registration Number: PACTR202209521256638
• Lead Sponsor: niversity of Zaragoza

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 174

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

•Children < 5 years and adults >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified