- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01059123
Short Course of Amoxicillin for Erysipelas (SHARE)
February 6, 2014 updated by: Assistance Publique - Hôpitaux de Paris
Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
Ile de France
-
Créteil, Ile de France, France, 94000
- Hôpital Henri Mondor - Service de dermatologie
-
-
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:
- Males and females ≥ 18 years of age
First episode of erysipelas of a lower leg defined as
- acute well delineate inflammation than had lasted less than 5 days
- T°≥ 38°5 at least once during the past 5 days or chills.
- Score ≥3 : oedema, erythema, pain each scored from 0 to 3 : 0= none, 1= moderate, 3= severe
- Written informed consent provided by the patient
- available health insurance
- accept conditions of the trial
Exclusion Criteria:
- Erysipelas for more than 5 days
- Score < 3
- Septic shock
- Clinical signs of necrotizing cellulitis or fasciitis, bullous lesions related to necrosis, purpuric lesions or superficial cutaneous necrosis.
- Past history of erysipelas of the same lower leg
- Erysipelas not on the lower leg
- Bilateral erysipelas
- Bite occuring during the preceding 7 days.
- Diabetic foot
- patients who have previously received systemic antibiotherapy within the last 5 days (except one or two doses within last 24 hours)
- History of any hypersensitivity or allergic reaction to beta-lactam drugs
- Known renal or Hepatic failure
- Known HIV infection
- Female patients who are pregnant, lactating (breast milk feeding), or who are of child bearing potential and not using an acceptable method of birth control
- Impossibility to stop immunosuppressive treatment, systemic corticosteroids or nonsteroidal anti-inflammatory drugs.
- Severe gastrointestinal disease, dysphagia or any pathology preventing oral administration of treatment.
- Denied to sign written informed consent
- Unable or unwilling to adhere to the study-specified procedures and restrictions
- Evolutive cancer under treatment
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 |
---|---|
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
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.
|
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 ; Per Os ; 3 times/day 6 days
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)
Time Frame: Day 30 ± 5
|
Day 30 ± 5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to obtain disappearance of fever and local signs
Time Frame: up to day 30 ± 5
|
up to day 30 ± 5
|
Relapse rate
Time Frame: end of treatment to day 30± 5
|
end of treatment to day 30± 5
|
Recurrence rate
Time Frame: day 30± 5 to day 95± 5
|
day 30± 5 to day 95± 5
|
Frequency of adverse events
Time Frame: 30 days ± 5
|
30 days ± 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Olivier CHOSIDOW, MD,PhD, Assistance Publique - Hôpitaux de Paris
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
September 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
January 28, 2010
First Submitted That Met QC Criteria
January 28, 2010
First Posted (Estimate)
January 29, 2010
Study Record Updates
Last Update Posted (Estimate)
February 7, 2014
Last Update Submitted That Met QC Criteria
February 6, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P071207
- 2008-006794-32 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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-
University of NottinghamUK Dermatology Clinical Trials Network; Action Medical ResearchCompletedCellulitis/Erysipelas of the LegUnited Kingdom, Ireland
-
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