Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis (C H R O N O S)

Tourcoing Hospital

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: duration of the antibiotic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02123628

2006-00625-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

antibiotic therapy

Active Comparator group

Description:

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

Treatment:

Drug: duration of the antibiotic therapy

12 week-duration of antibiotic therapy

Active Comparator group

Description:

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

Treatment:

Drug: duration of the antibiotic therapy