NCT02624882

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

November 25, 2015

Last Update Submit

August 1, 2018

Conditions

Blistering Distal Dactylitis

Keywords

blistering distal dactylitisStreptococcus pyogenesantibiotics

Outcome Measures

Primary Outcomes (1)

  • Rate healed blistering distal dactylitis with positive GAS test after 10 days of antibiotherapy directed against streptococcus pyogenes

    The main objective of this study is to evaluate the effectiveness of antibiotic treatment only if paronychia subungual child collected or not collected with a in distal blistering dactylitis with positive GAS test

    10 days

Secondary Outcomes (11)

  • Frequency of distal blistering dactylitis with positive GAS test in children

    18 months

  • Frequency of collected distal blistering dactylitis with positive GAS test in children

    18 months

  • Frequency of germs involved in distal blistering dactylitis after pus culture in children

    18 months

  • Sensitivity of GAS test compared to pus culture

    18 months

  • Specificity of GAS test compared to pus culture

    18 months

  • +6 more secondary outcomes

Study Arms (2)

Positive rapid Group A Streptococcus (GAS) test

EXPERIMENTAL

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

Procedure: Positive rapid GAS test

Negative rapid GAS test

ACTIVE COMPARATOR

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

Procedure: Negative rapid GAS test

Interventions

Positive rapid GAS testPROCEDURE

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.

Positive rapid Group A Streptococcus (GAS) test
Negative rapid GAS testPROCEDURE

Usual care

Negative rapid GAS test

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Subungual or pulp Whitlow
  • Children not affiliated to the social security scheme
  • Refusal by the parents to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHI Creteil

Créteil, 94000, France

Location

Study Officials

  • Camille Jung, MD, PhD

    CHIC Créteil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 9, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

August 2, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)