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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02624882
Acronym
TAPPS
Enrollment
177
Registered
2015-12-09
Start date
2015-11-30
Completion date
2018-03-31
Last updated
2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blistering Distal Dactylitis

Keywords

blistering distal dactylitis, Streptococcus pyogenes, antibiotics

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.

Interventions

PROCEDUREPositive 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.

PROCEDURENegative rapid GAS test

Usual care

Sponsors

Camille JUNG
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate healed blistering distal dactylitis with positive GAS test after 10 days of antibiotherapy directed against streptococcus pyogenes10 daysThe 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

MeasureTime frameDescription
Frequency of collected distal blistering dactylitis with positive GAS test in children18 months
Frequency of germs involved in distal blistering dactylitis after pus culture in children18 months
Sensitivity of GAS test compared to pus culture18 monthsDescribe the sensitivity of GAS test in distal blistering dactylitis according to different age groups.
Specificity of GAS test compared to pus culture18 monthsDescribe the specificity of GAS test in distal blistering dactylitis according to different age groups.
Correlation between GAS test and pus culture in different age groups18 months
Frequency of distal blistering dactylitis with positive GAS test in children18 months
Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis18 months
Comparison between the cost of antibiotics versus surgical or local treatments of positive GAS test distal blistering dactylitis in children18 monthsEvaluate 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 treatment18 months
Number of Nail dystrophy at 3 months of follow-up3 months
Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis18 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026