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

NCT02123628 | Completed Phase 4

• 1 other identifier: 2006-00625-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

diabetic foot osteomyelitis, antibiotic treatment duration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• tolerance to treatment in each group of patients

  6 or 12 weeks

Study Arms (2)

antibiotic therapy

ACTIVE COMPARATOR

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

12 week-duration of antibiotic therapy

ACTIVE COMPARATOR

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

Interventions

duration of the antibiotic therapy DRUG

Also known as: - Rifampin, - Levofloxacin, - Doxycycline, - Trimethoprim- sulfamethoxazole, - Fusidic acid, - Linezolid, - Ciprofloxacin, - Cefotaxime, - Ceftriaxone, - Cefepime

12 week-duration of antibiotic therapy; antibiotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Tourcoing Hospital: lead

Study Sites (1)

Dron Hospital

Tourcoing, Nord, 59200, France

Location

Related Publications (1)

• Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand E, Lemaire C, Senneville E. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study. Diabetes Care. 2015 Feb;38(2):302-7. doi: 10.2337/dc14-1514. Epub 2014 Nov 20.

  PMID: 25414157 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Rifampin; Levofloxacin; Doxycycline; Trimethoprim, Sulfamethoxazole Drug Combination; Fusidic Acid; Linezolid; Ciprofloxacin; Cefotaxime; Ceftriaxone; Cefepime

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations; Cholestadienols; Cholestadienes; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Sterols; Membrane Lipids; Lipids; Acetamides; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Thiazines

Study Officials

• Eric M Senneville, MD, PhD

  Dron Hospital of Tourcoing France

  STUDY DIRECTOR

• Alina Tone, MD

  Dron Hospital Tourcoing France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 25, 2014
• Study Start: June 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2012
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

FR (1)