Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: duration of the antibiotic therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: antibiotic therapy<br>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 | Drug: duration of the antibiotic therapy<br> <br> * Other names: - Cefepime;|
| Active Comparator: 12 week-duration of antibiotic therapy<br>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 | Drug: duration of the antibiotic therapy<br> <br> * Other names: - Cefepime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up. | 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerance to treatment in each group of patients | number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients. | 6 or 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot osteomyelitis, antibiotic treatment duration