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

Study Overview
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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.

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

Conditions
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Blistering Distal Dactylitis

Intervention / Treatment
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* Procedure: Positive rapid GAS test
* Procedure: Negative rapid GAS test


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive rapid Group A Streptococcus (GAS) test<br>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<br>* 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.<br>|
| Active Comparator: Negative rapid GAS test<br>If case of negative rapid GAS test, usual care: local antiseptic or surgical intervention | Procedure: Negative rapid GAS test<br>* Usual care<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blistering distal dactylitis, Streptococcus pyogenes, antibiotics