140
Participants
Start Date
December 1, 2021
Primary Completion Date
May 31, 2026
Study Completion Date
May 31, 2026
Standard [RC8]: rifampicin plus clarithromycin (RC) therapy for 8 weeks.
Treatment will be rifampicin (600 mg, daily) and clarithromycin (500 mg, twice daily) for 8 weeks. On the posology, dosage for rifampicin and clarithromycin will be standardized according to patient body weight following WHO guidelines. In general, for a 60 kg adult dosage will be RIF, 10 mg/kg once daily and CLA, 7.5 mg/kg twice daily.
Investigational [RCA4]: standard (RC) plus amoxicillin/clavulanate (A) for 4 weeks.
"On the posology, dosage for rifampicin and clarithromycin will be standardized according to patient body weight following WHO guidelines. In general, for a 60 kg adult dosage will be RIF, 10 mg/kg once daily and CLA, 7.5 mg/kg twice daily.~Dosages for amoxicillin/clavulanate are calculated according to manufacturer indications:~Dose of amoxicillin/clavulanate 1000/125 mg twice daily, which makes a total of 2000/250 mg/day, for patients over 40 kg, and 22.5/5.6 mg/kg twice daily, which makes a total of 45/11.25 mg/kg/day, for those equal and below 40 kg. For children, posology will be adapted to the age of the patient according to drug manufacturer indications. Frequency of AMX/CLV administration will match that of CLA, twice daily."
RECRUITING
Centre de Dépistage et de Traitement de l'Ulcère de Buruli (CDTUB) (Centers for Detection and Treatment of Buruli ulcer), Allada, Allada
RECRUITING
Centre de Dépistage et de Traitement de l'Ulcère de Buruli (CDTUB) (Centers for Detection and Treatment of Buruli ulcer), Lalo, Lalo
RECRUITING
Centre de Dépistage et de Traitement de l'Ulcère de Buruli (CDTUB) (Centers for Detection and Treatment of Buruli ulcer), Pobè, Pobè
Collaborators (1)
Universidad de Zaragoza
OTHER
Fondation Raoul Follereau
UNKNOWN
Université d'Abomey-Calavi
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Fundación Anesvad
UNKNOWN
Tres Cantos Open Lab Foundation
UNKNOWN
GlaxoSmithKline
INDUSTRY
Fundacion Agencia Aragonesa para la Investigacion y Desarrollo (ARAID)
OTHER