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

Blistering Distal Dactylitis Clinical Trial

— TAPPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624882
• Other study ID #: TAPPS
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Blister
• Blistering Distal Dactylitis

Intervention

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.
• Negative rapid GAS test
Usual care

Locations

Country	Name	City	State
France	CHI Creteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Camille JUNG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of distal blistering dactylitis with positive GAS test in children		18 months
Secondary	Frequency of collected distal blistering dactylitis with positive GAS test in children		18 months
Secondary	Frequency of germs involved in distal blistering dactylitis after pus culture in children		18 months
Secondary	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
Secondary	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
Secondary	Correlation between GAS test and pus culture in different age groups		18 months
Secondary	Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis		18 months
Secondary	Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis		18 months
Secondary	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
Secondary	Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment		18 months
Secondary	Number of Nail dystrophy at 3 months of follow-up		3 months