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

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
duration of the antibiotic therapy
Sponsored by
Tourcoing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetic foot osteomyelitis, antibiotic treatment duration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dron Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

antibiotic therapy

12 week-duration of antibiotic therapy

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 15, 2014
Last Updated
April 22, 2014
Sponsor
Tourcoing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02123628
Brief Title
Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis
Acronym
C H R O N O S
Official Title
Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tourcoing Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
diabetic foot osteomyelitis, antibiotic treatment duration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
antibiotic therapy
Arm Type
Active Comparator
Arm 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
Arm Title
12 week-duration of antibiotic therapy
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
duration of the antibiotic therapy
Other Intervention Name(s)
- Rifampin, - Levofloxacin, - Doxycycline, - Trimethoprim- sulfamethoxazole, - Fusidic acid, - Linezolid, - Ciprofloxacin, - Cefotaxime, - Ceftriaxone, - Cefepime
Primary Outcome Measure Information:
Title
Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
tolerance to treatment in each group of patients
Description
number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients.
Time Frame
6 or 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric M Senneville, MD, PhD
Organizational Affiliation
Dron Hospital of Tourcoing France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alina Tone, MD
Organizational Affiliation
Dron Hospital Tourcoing France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dron Hospital
City
Tourcoing
State/Province
Nord
ZIP/Postal Code
59200
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25414157
Citation
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. Erratum In: Diabetes Care. 2015 Apr;38(4):735.
Results Reference
derived

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

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