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

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ClinicalTrials.gov Identifier: NCT02123628
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: duration of the antibiotic therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study
Study Start Date : June 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: duration of the antibiotic therapy
Other Names:
  • - Rifampin
  • - Levofloxacin
  • - Doxycycline
  • - Trimethoprim- sulfamethoxazole
  • - Fusidic acid
  • - Linezolid
  • - Ciprofloxacin
  • - Cefotaxime
  • - Ceftriaxone
  • - Cefepime

Active Comparator: 12 week-duration of 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
Drug: duration of the antibiotic therapy
Other Names:
  • - Rifampin
  • - Levofloxacin
  • - Doxycycline
  • - Trimethoprim- sulfamethoxazole
  • - Fusidic acid
  • - Linezolid
  • - Ciprofloxacin
  • - Cefotaxime
  • - Ceftriaxone
  • - Cefepime




Primary Outcome Measures :
  1. Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up. [ Time Frame: 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 :
  1. tolerance to treatment in each group of patients [ Time Frame: 6 or 12 weeks ]
    number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123628


Locations
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France
Dron Hospital
Tourcoing, Nord, France, 59200
Sponsors and Collaborators
Tourcoing Hospital
Investigators
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Study Director: Eric M Senneville, MD, PhD Dron Hospital of Tourcoing France
Principal Investigator: Alina Tone, MD Dron Hospital Tourcoing France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tourcoing Hospital
ClinicalTrials.gov Identifier: NCT02123628     History of Changes
Other Study ID Numbers: 2006-00625-14
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Keywords provided by Tourcoing Hospital:
diabetic foot osteomyelitis, antibiotic treatment duration
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Antineoplastic Agents
Leprostatic Agents
Anti-Dyskinesia Agents
Osteomyelitis
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Doxycycline