Short Course of Amoxicillin for Erysipelas

NCT01059123 | Terminated Phase 4

• 2 other identifiers: P0712072008-006794-32
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Erysipelas

Keywords

Amoxicillin; Erysipelas; Short course

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)

  Day 30 ± 5

Secondary Outcomes (4)

• 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

  day 30± 5 to day 95± 5

• Frequency of adverse events

  30 days ± 5

Study Arms (2)

1:Short treatment

EXPERIMENTAL

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

Drug: Amoxicillin

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.

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

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

1:Short treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• Société de Dermatologie Française: collaborator

Study Sites (1)

Hôpital Henri Mondor - Service de dermatologie

Créteil, Île-de-France Region, 94000, France

Location

MeSH Terms

Conditions

Erysipelas

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Olivier CHOSIDOW, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

FR (1)