Comparison of 8 weeks standard treatment (rifampicin plus clarithromycin) vs. 4 weeks standard plus amoxicillin/clavulanate treatment [RC8 vs. RCA4] to shorten Buruli ulcer disease therapy (the BLMs4BU trial): study protocol for a randomized controlled multi-centre trial in Benin

Table 2 Clinical trial treatment cohort regimens

Treatment cohort	Dose	Posology	Treatment length
Standard arm: [RC8]	¹Rifampicin 600 mg	Daily	8 weeks
	¹Clarithromycin 500 mg	Twice daily	8 weeks
Investigational arm: [RCA4]	¹Rifampicin 600 mg	Daily	4 weeks
	¹Clarithromycin 500 mg	Twice daily	4 weeks
	²Amoxicillin/clavulanate 1000/125 mg	Twice daily	4 weeks

¹Dose indicated are for a 60 kg adult and will be standardized according to patient body weight following the WHO guidelines [31]. Rifampicin (R), 10 mg/kg; Clarithromycin (C) 7.5 mg/kg
²Dose of amoxicillin/clavulanate (A) 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. There are no current recommendations for the use of amoxicillin/clavulanate for BU infections. Those indicated above are recommended doses for complicated infections according to manufacturer indications

ISSN: 1745-6215