Short Course of Amoxicillin for Erysipelas

Erysipelas Clinical Trial

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Official title:

Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01059123
• Other study ID #: P071207
• Secondary ID: 2008-006794-32
• Status: Terminated
• Phase: Phase 4
• First received: January 28, 2010
• Last updated: February 6, 2014
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: February 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erysipelas

Intervention

Drug:
• Amoxicillin
50 mg/kg/24H ; Per Os ; 3 times/day 6 days
• 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.

Locations

Country	Name	City	State
France	Hôpital Henri Mondor - Service de dermatologie	Créteil	Ile de France

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France, Société de Dermatologie Française

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate defined as body temperature = 37,5°and disappearance of the cutaneous plaque (score=o)		Day 30 ± 5	No
Secondary	Time to obtain disappearance of fever and local signs		up to day 30 ± 5	No
Secondary	Relapse rate		end of treatment to day 30± 5	No
Secondary	Recurrence rate		day 30± 5 to day 95± 5	No
Secondary	Frequency of adverse events		30 days ± 5	No