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

Primary Purpose

Blistering Distal Dactylitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positive rapid GAS test
Negative rapid GAS test
Sponsored by
Camille JUNG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Blistering Distal Dactylitis focused on measuring blistering distal dactylitis, Streptococcus pyogenes, antibiotics

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHI Creteil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive rapid Group A Streptococcus (GAS) test

Negative rapid GAS test

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of distal blistering dactylitis with positive GAS test in children
Frequency of collected distal blistering dactylitis with positive GAS test in children
Frequency of germs involved in distal blistering dactylitis after pus culture in children
Sensitivity of GAS test compared to pus culture
Describe the sensitivity of GAS test in distal blistering dactylitis according to different age groups.
Specificity of GAS test compared to pus culture
Describe the specificity of GAS test in distal blistering dactylitis according to different age groups.
Correlation between GAS test and pus culture in different age groups
Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis
Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis
Comparison between the cost of antibiotics versus surgical or local treatments of positive GAS test distal blistering dactylitis in children
Evaluate the medical and economic impact of the single antibiotic treatment of distal blistering dactylitis with positive GAS test
Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment
Number of Nail dystrophy at 3 months of follow-up

Full Information

First Posted
November 25, 2015
Last Updated
August 1, 2018
Sponsor
Camille JUNG
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1. Study Identification

Unique Protocol Identification Number
NCT02624882
Brief Title
Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children
Acronym
TAPPS
Official Title
Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Camille JUNG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blistering Distal Dactylitis
Keywords
blistering distal dactylitis, Streptococcus pyogenes, antibiotics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive rapid Group A Streptococcus (GAS) test
Arm Type
Experimental
Arm Description
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
Arm Title
Negative rapid GAS test
Arm Type
Active Comparator
Arm Description
If case of negative rapid GAS test, usual care: local antiseptic or surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Positive rapid GAS test
Intervention Description
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
Intervention Name(s)
Negative rapid GAS test
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Rate healed blistering distal dactylitis with positive GAS test after 10 days of antibiotherapy directed against streptococcus pyogenes
Description
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
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Frequency of distal blistering dactylitis with positive GAS test in children
Time Frame
18 months
Title
Frequency of collected distal blistering dactylitis with positive GAS test in children
Time Frame
18 months
Title
Frequency of germs involved in distal blistering dactylitis after pus culture in children
Time Frame
18 months
Title
Sensitivity of GAS test compared to pus culture
Description
Describe the sensitivity of GAS test in distal blistering dactylitis according to different age groups.
Time Frame
18 months
Title
Specificity of GAS test compared to pus culture
Description
Describe the specificity of GAS test in distal blistering dactylitis according to different age groups.
Time Frame
18 months
Title
Correlation between GAS test and pus culture in different age groups
Time Frame
18 months
Title
Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis
Time Frame
18 months
Title
Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis
Time Frame
18 months
Title
Comparison between the cost of antibiotics versus surgical or local treatments of positive GAS test distal blistering dactylitis in children
Description
Evaluate the medical and economic impact of the single antibiotic treatment of distal blistering dactylitis with positive GAS test
Time Frame
18 months
Title
Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment
Time Frame
18 months
Title
Number of Nail dystrophy at 3 months of follow-up
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille Jung, MD, PhD
Organizational Affiliation
CHIC Créteil
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHI Creteil
City
Créteil
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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