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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006794-32 | EudraCT Number |
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Insufficient number of inclusion
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Société de Dermatologie Française | OTHER |
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The propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. This trial will be open but evaluation will be perform by a blind evaluator.
To fight against increasing rate of bacterial resistance to antibiotics, several studies have demonstrated efficacy of short antibiotic course in e.g. acute streptococcal tonsillitis, community acquired pneumonia, and urinary tract infection. Erysipelas is an acute dermo-hypodermal infection due to streptococcus. To date no resistance of theses bacteria to amoxicillin was described. The diagnosis of erysipelas is clinical. Thus, short course of antibiotic is a good regimen to test in erysipelas treatment. To date there is no controlled trial concerning efficacy of oral amoxicillin in erysipelas treatment. Expected advantages of the demonstration of the non inferiority of a short and oral amoxicillin treatment in erysipelas are: reduction of antibiotic selective pressure, cost, adverse events caused by infusion and hospitalisation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1:Short treatment | Experimental | amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days. |
|
| 2:Usual treatment | Active Comparator | amoxicillin 50 mg/kg/24H ; I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day up to day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | 50 mg/kg/24H ; Per Os ; 3 times/day 6 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o) | Day 30 ± 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to obtain disappearance of fever and local signs | up to day 30 ± 5 | |
| Relapse rate | end of treatment to day 30± 5 | |
| Recurrence rate |
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Inclusion Criteria:
Males and females ≥ 18 years of age
First episode of erysipelas of a lower leg defined as
Written informed consent provided by the patient
available health insurance
accept conditions of the trial
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier CHOSIDOW, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor - Service de dermatologie | Créteil | Île-de-France Region | 94000 | France |
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| ID | Term |
|---|---|
| D004886 | Erysipelas |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Amoxicillin |
| Drug |
50 mg/kg/24H in I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; Per Os ; 3 times/day up to day 14. |
|
| day 30± 5 to day 95± 5 |
| Frequency of adverse events | 30 days ± 5 |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |