Lipsky 1997.

Methods	Design: randomised controlled trial, multicentre (12 centres), national (USA) Follow‐up period: not described
Participants	N: 180 participants randomised Age (mean (range)): 61.5 years (31‐90) Sex (%men): 84% Inclusion criteria: ≥18 years; diabetes mellitus; foot infection requiring antibiotic therapy; purulent drainage or erythema or swelling Exclusion criteria: osteomyelitis if all of the infected bone was not to be removed soon; presence of micro‐organisms resistant to the study drugs; underweight; seizures; major psychiatric disorder; pregnancy or lactation; renal replacement therapy; poor prognosis; antibiotic 48 h before study; antibiotic for any other reason; allergy to study drugs
Interventions	Intervention (n = 55): ofloxacin 400 mg iv every 12 h. Changed when appropriate to ofloxacin 400 mg po every 12 h Control (n = 53): ampicillin‐sulbactam 1‐2 g/0.5‐1 g iv every 6 h (initial dose depended on severity). Switched to amoxicillin‐clavulanate 500 mg/125 mg po every 8 h when appropriate Co‐interventions: wound care; additional antibiotic could be added if participant did not respond: in Intervention Group metronidazole added (n = 5); in Control Group, gentamicin, trimethoprim‐sulfamethoxazole or another (n = 42) Treatment duration: 14‐28 days
Outcomes	Clinical response Microbiological response Adverse events Superinfection
Notes	Funding source: Department of Veterans Affairs and the Robert Wood Johnson Pharmaceutical Research Institute Other: no sample size calculation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomised but the sequence generation was not described
Allocation concealment (selection bias)	Unclear risk	No information reported
Incomplete outcome data (attrition bias) All outcomes	High risk	19% of participants excluded with no balanced reasons. No ITT analyses
Selective reporting (reporting bias)	Unclear risk	No data on superinfection. Author contacted and no data available
Other bias	Unclear risk	N/A
Blinding of participants and personnel (performance bias) All outcomes	High risk	Initial dose of ampicillin‐ofloxacin chosen by investigator
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information reported