Clinical trial NCT02624882: Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children
Official title: Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blistering Distal Dactylitis
Keywords: blistering distal dactylitis
Streptococcus pyogenes
antibiotics
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 177
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Rate healed blistering distal dactylitis with positive GAS test after 10 days of antibiotherapy directed against streptococcus pyogenes
timeFrame: 10 days
Secondary outcomes:
measure: Frequency of distal blistering dactylitis with positive GAS test in children
timeFrame: 18 months
measure: Frequency of collected distal blistering dactylitis with positive GAS test in children
timeFrame: 18 months
measure: Frequency of germs involved in distal blistering dactylitis after pus culture in children
timeFrame: 18 months
measure: Sensitivity of GAS test compared to pus culture
timeFrame: 18 months
measure: Specificity of GAS test compared to pus culture
timeFrame: 18 months
measure: Correlation between GAS test and pus culture in different age groups
timeFrame: 18 months
measure: Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis
timeFrame: 18 months
measure: Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis
timeFrame: 18 months
measure: Comparison between the cost of antibiotics versus surgical or local treatments of positive GAS test distal blistering dactylitis in children
timeFrame: 18 months
measure: Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment
timeFrame: 18 months
measure: Number of Nail dystrophy at 3 months of follow-up
timeFrame: 3 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Creteil
Study officials:
affiliation: CHIC Créteil
name: Camille Jung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: