Short Course of Amoxicillin for Erysipelas

NCT ID: NCT01059123

Last Updated: 2014-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-07-31

Brief Summary

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.

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.

Conditions

Erysipelas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1:Short treatment

amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

50 mg/kg/24H ; Per Os ; 3 times/day 6 days

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.

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: 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.

Interventions

Amoxicillin

50 mg/kg/24H ; Per Os ; 3 times/day 6 days

Intervention Type: DRUG

Amoxicillin

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Société de Dermatologie Française

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier CHOSIDOW, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Henri Mondor - Service de dermatologie

Créteil, Île-de-France Region, France

Countries

France

Other Identifiers

2008-006794-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P071207

Identifier Type: -

Identifier Source: org_study_id