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Short Course of Amoxicillin for Erysipelas

Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erysipelas

Intervention: Amoxicillin (Drug); Amoxicillin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Olivier CHOSIDOW, MD,PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Overall contact:
Olivier CHOSIDOW, MD,PhD, Phone: 33 (0) 1 49 81 25 01, Email: olivier.chosidow@hmn.aphp.fr

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.

Clinical Details

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

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

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

Secondary outcome:

Time to obtain disappearance of fever and local signs

Relapse rate

Recurrence rate

Frequency of adverse events

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 12 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

Locations and Contacts

Olivier CHOSIDOW, MD,PhD, Phone: 33 (0) 1 49 81 25 01, Email: olivier.chosidow@hmn.aphp.fr

Hôpital Henri Mondor - Service de dermatologie, Créteil, Ile de France 94000, France; Not yet recruiting
Olivier CHOSIDOW, MD,PhD, Phone: +33 (0) 1 49 81 25 01, Email: olivier.chosidow@hmn.aphp.fr
Laurence LECLEACH, MD, Email: laurence.lecleach@free.fr
Additional Information

Starting date: February 2010
Last updated: September 9, 2011

Page last updated: February 07, 2013

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