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Completed

NCT Number: NCT02624882

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

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

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Key information

Conditions

Blistering Distal Dactylitis

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHI Creteil

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive rapid GAS test

Procedure

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

Procedure

Usual care

Primary outcomes

  1. Rate healed blistering distal dactylitis with positive GAS test after 10 days of antibiotherapy directed against streptococcus pyogenes

    Time frame: 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 outcomes

  1. Frequency of distal blistering dactylitis with positive GAS test in children

    Time frame: 18 months

  2. Frequency of collected distal blistering dactylitis with positive GAS test in children

    Time frame: 18 months

  3. Frequency of germs involved in distal blistering dactylitis after pus culture in children

    Time frame: 18 months

  4. Sensitivity of GAS test compared to pus culture

    Time frame: 18 months

    Describe the sensitivity of GAS test in distal blistering dactylitis according to different age groups.

  5. Specificity of GAS test compared to pus culture

    Time frame: 18 months

    Describe the specificity of GAS test in distal blistering dactylitis according to different age groups.

  6. Correlation between GAS test and pus culture in different age groups

    Time frame: 18 months

  7. Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis

    Time frame: 18 months

  8. Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis

    Time frame: 18 months

  9. Comparison between the cost of antibiotics versus surgical or local treatments of positive GAS test distal blistering dactylitis in children

    Time frame: 18 months

    Evaluate the medical and economic impact of the single antibiotic treatment of distal blistering dactylitis with positive GAS test

  10. Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment

    Time frame: 18 months

  11. Number of Nail dystrophy at 3 months of follow-up

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Camille JUNG

Other

Registry information

Acronym: TAPPS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2015
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.