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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antibiotic therapy | Active Comparator | patients are treated with a 6 week-duration of antibiotic therapy :
|
|
| 12 week-duration of antibiotic therapy | Active Comparator | patients are treated with a 12 week-duration of antibiotic therapy :
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duration of the antibiotic therapy | Drug |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric M Senneville, MD, PhD | Dron Hospital of Tourcoing France | Study Director |
| Alina Tone, MD | Dron Hospital Tourcoing France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dron Hospital | Tourcoing | Nord | 59200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25414157 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| D064704 | Levofloxacin |
| D004318 | Doxycycline |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| D005672 | Fusidic Acid |
| D000069349 | Linezolid |
| D002939 | Ciprofloxacin |
| D002439 | Cefotaxime |
| D002443 | Ceftriaxone |
| D000077723 | Cefepime |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002775 | Cholestadienols |
| D002774 | Cholestadienes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D013843 | Thiazines |