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

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

Study Overview

• Status: Completed
• Conditions: Blistering Distal Dactylitis
• Intervention / Treatment: Procedure: Positive rapid GAS test; Procedure: Negative rapid GAS test

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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • CHI Creteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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.
Active Comparator: Negative rapid GAS test; If case of negative rapid GAS test, usual care: local antiseptic or surgical intervention	Procedure: Negative rapid GAS test; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Describe the sensitivity of GAS test in distal blistering dactylitis according to different age groups.	18 months
Specificity of GAS test compared to pus culture	Describe the specificity of GAS test in distal blistering dactylitis according to different age groups.	18 months
Correlation between GAS test and pus culture in different age groups		18 months
Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis		18 months
Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis		18 months
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	18 months
Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment		18 months
Number of Nail dystrophy at 3 months of follow-up		3 months

Collaborators and Investigators

• Sponsor: Camille JUNG
• Investigators: Principal Investigator: Camille Jung, MD, PhD, CHIC Créteil

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: antibiotics; Streptococcus pyogenes; blistering distal dactylitis
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Vesiculobullous; Blister
• Other Study ID Numbers: TAPPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No