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

Not Applicable

Completed

• Conditions: Blistering Distal Dactylitis
• Interventions: Procedure: Positive rapid GAS test; Procedure: Negative rapid GAS test

• Registration Number: NCT02624882
• Lead Sponsor: Camille JUNG

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-09
• Primary Completion: 2018-01
• Study Completion: 2018-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Positive rapid Group A Streptococcus (GAS) test	Positive rapid 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
Negative rapid GAS test	Negative rapid GAS test	If case of negative rapid GAS test, usual care: local antiseptic or surgical intervention

Primary Outcome Measures

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

Name	Time	Method
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	Describe the sensitivity of GAS test in distal blistering dactylitis according to different age groups.
Frequency of distal blistering dactylitis with positive GAS test in children	18 months
Specificity of GAS test compared to pus culture	18 months	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	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	18 months	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	18 months
Number of Nail dystrophy at 3 months of follow-up	3 months

Trial Locations

Locations (1)

CHI Creteil; 🇫🇷 Créteil, France