Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children

NCT ID: NCT02624882

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-03-31

Brief Summary

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Single-center prospective study to assess the clinical course of group A streptococcal blistering distal dactylitis in children after antibiotic treatment.

Detailed Description

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Blistering distal dactylitis are very common in children. About 60% are caused by Staphylococcus aureus and some are caused by Group A Streptococcus (GAS) or Streptococcus pyogenes. While these forms have been known for fifty years, few publications are interested in it. Some studies have confirmed that a single antibiotic treatment against the SGA allows the healing of these dactylitis but few surgical teams have adopted this strategy. As all streptococcal infections, they face the risk of acute complications (septicemia, streptococcal toxic shock, etc.) or late (post-streptococcal glomerulonephritis, acute rheumatic fever, etc.). The involvement of the SGA in these dactylitis is easy to demonstrate through the use of rapid GAS test already widely used in other GAS infections (tonsillitis, scarlet fever, streptococcal perianal infections).

This study aims to assess the clinical course of positive GAS test blistering distal dactylitis in children after antibiotic treatment.

Conditions

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Blistering Distal Dactylitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Positive rapid Group A Streptococcus (GAS) test

In case of positive rapid GAS test, patients will be treated by antibiotics: amoxicillin 50mg/kg/d during 10 days or cefpodoxime 8mg/kg/d during 10 days in case of betalactamine allergy

Group Type EXPERIMENTAL

Positive rapid GAS test

Intervention Type PROCEDURE

If TDR positive, the child will be treated with antibiotics alone:

* Amoxicillin 50mg / kg / day in 2 divided doses for 10 days (maximum dose 3 g / day in 2 divided doses) Or if allergic to penicillins and in the absence of cross-known allergy to cephalosporins
* Cefpodoxime 8mg / kg / day in 2 divided doses for 10 days (maximum dose 400mg / day in 2 divided doses) J10 A control visit will review all the children included in the study. If the surgeon deems it necessary, the patient will be reviewed in consultation up to three months.

Negative rapid GAS test

If case of negative rapid GAS test, usual care: local antiseptic or surgical intervention

Group Type ACTIVE_COMPARATOR

Negative rapid GAS test

Intervention Type PROCEDURE

Usual care

Interventions

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Positive rapid GAS test

If TDR positive, the child will be treated with antibiotics alone:

* Amoxicillin 50mg / kg / day in 2 divided doses for 10 days (maximum dose 3 g / day in 2 divided doses) Or if allergic to penicillins and in the absence of cross-known allergy to cephalosporins
* Cefpodoxime 8mg / kg / day in 2 divided doses for 10 days (maximum dose 400mg / day in 2 divided doses) J10 A control visit will review all the children included in the study. If the surgeon deems it necessary, the patient will be reviewed in consultation up to three months.

Intervention Type PROCEDURE

Negative rapid GAS test

Usual care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children 0-18 years
* Distal blistering dactylitis collected or not collected
* Positive rapid Group A Streptococcus test
* Informed consent signed by the parents

Exclusion Criteria

* Subungual or pulp Whitlow
* Children not affiliated to the social security scheme
* Refusal by the parents to participate in the study
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Camille JUNG

OTHER

Sponsor Role lead

Responsible Party

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Camille JUNG

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Camille Jung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHIC Créteil

Locations

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CHI Creteil

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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TAPPS

Identifier Type: -

Identifier Source: org_study_id

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