Short Course of Amoxicillin for Erysipelas (SHARE)
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|ClinicalTrials.gov Identifier: NCT01059123|
Recruitment Status : Terminated (Insufficient number of inclusion)
First Posted : January 29, 2010
Last Update Posted : February 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Erysipelas||Drug: Amoxicillin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Experimental: 1:Short treatment
amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.
50 mg/kg/24H ; Per Os ; 3 times/day 6 days
Active Comparator: 2:Usual treatment
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.
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.
- Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o) [ Time Frame: Day 30 ± 5 ]
- Time to obtain disappearance of fever and local signs [ Time Frame: up to day 30 ± 5 ]
- Relapse rate [ Time Frame: end of treatment to day 30± 5 ]
- Recurrence rate [ Time Frame: day 30± 5 to day 95± 5 ]
- Frequency of adverse events [ Time Frame: 30 days ± 5 ]
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): NCT01059123
|Hôpital Henri Mondor - Service de dermatologie|
|Créteil, Ile de France, France, 94000|
|Principal Investigator:||Olivier CHOSIDOW, MD,PhD||Assistance Publique - Hôpitaux de Paris|