- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02123628
Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis (C H R O N O S)
April 22, 2014 updated by: Tourcoing Hospital
Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nord
-
Tourcoing, Nord, France, 59200
- Dron Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: antibiotic therapy
patients are treated with a 6 week-duration of antibiotic therapy :
|
Other Names:
|
Active Comparator: 12 week-duration of antibiotic therapy
patients are treated with a 12 week-duration of antibiotic therapy :
|
Other Names:
|
What is the study measuring?
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.
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 or 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eric M Senneville, MD, PhD, Dron Hospital of Tourcoing France
- Principal Investigator: Alina Tone, MD, Dron Hospital Tourcoing France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
April 15, 2014
First Submitted That Met QC Criteria
April 22, 2014
First Posted (Estimate)
April 25, 2014
Study Record Updates
Last Update Posted (Estimate)
April 25, 2014
Last Update Submitted That Met QC Criteria
April 22, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Infections
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Infectious
- Foot Ulcer
- Diabetic Foot
- Osteomyelitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Protein Synthesis Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Antiprotozoal Agents
- Antiparasitic Agents
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antimalarials
- Folic Acid Antagonists
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Linezolid
- Ceftriaxone
- Anti-Bacterial Agents
- Doxycycline
- Rifampin
- Ciprofloxacin
- Levofloxacin
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
- Fusidic Acid
- Cefotaxime
- Cefepime
Other Study ID Numbers
- 2006-00625-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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