Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis
- Conditions
- Diabetes Mellitus
- Interventions
- Drug: duration of the antibiotic therapy
- Registration Number
- NCT02123628
- Lead Sponsor
- Tourcoing Hospital
- Brief Summary
The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.
- Detailed Description
The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).
- Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description antibiotic therapy duration of the antibiotic therapy patients are treated with a 6 week-duration of antibiotic therapy : * Rifampin IP and PO twice daily, 10mg/kg /12H * Levofloxacin IV and PO 500-750mg once daily * Doxycycline PO 200mg once daily * Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily * Fusidic acid PO 500mg twice daily * Linezolid IV and PO 600mg twice daily * Ciprofloxacin IV and PO 750to 1000mg/12h * Cefotaxime IV 100mg/kg in three IV infusions daily * Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily * Cefepime IV ou intra-muscularly 2g /8-12h 12 week-duration of antibiotic therapy duration of the antibiotic therapy patients are treated with a 12 week-duration of antibiotic therapy : * Rifampin IP and PO twice daily, 10mg/kg /12H * Levofloxacin IV and PO 500-750mg once daily * Doxycycline PO 200mg once daily * Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily * Fusidic acid PO 500mg twice daily * Linezolid IV and PO 600mg twice daily * Ciprofloxacin IV and PO 750to 1000mg/12h * Cefotaxime IV 100mg/kg in three IV infusions daily * Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily * Cefepime IV ou intra-muscularly 2g /8-12h
- Primary Outcome Measures
Name Time Method Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up. one year Remission was defined as the absence of any sign of infection at the initial or a contiguous site, evaluated at least one year after the end of antibiotic treatment (ie at the end of follow-up), with neither a new infectious episode nor the need for orthopedic surgery of the foot at either of these sites during the treatment and follow-up period.
- Secondary Outcome Measures
Name Time Method tolerance to treatment in each group of patients 6 or 12 weeks number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients.
Trial Locations
- Locations (1)
Dron Hospital
🇫🇷Tourcoing, Nord, France