Beta-Lactam Containing Regimen for the Shortening of Buruli Ulcer Disease Therapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Buruli Ulcer
Interventions
DRUG

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.

DRUG

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."

Trial Locations (3)

Unknown

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Universidad de Zaragoza

OTHER

collaborator

Fondation Raoul Follereau

UNKNOWN

collaborator

Université d'Abomey-Calavi

OTHER

collaborator

Instituto de Salud Carlos III

OTHER_GOV

collaborator

Fundación Anesvad

UNKNOWN

collaborator

Tres Cantos Open Lab Foundation

UNKNOWN

collaborator

GlaxoSmithKline

INDUSTRY

lead

Fundacion Agencia Aragonesa para la Investigacion y Desarrollo (ARAID)

OTHER

NCT05169554 - Beta-Lactam Containing Regimen for the Shortening of Buruli Ulcer Disease Therapy | Biotech Hunter | Biotech Hunter