Blistering Distal DactylitisTAPPSNCT02624882
Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children
A study testing Positive rapid GAS test and Negative rapid GAS test in people with Blistering Distal Dactylitis, run by Camille JUNG at 1 site in France.
Trial summary
Single-center prospective study to assess the clinical course of group A streptococcal blistering distal dactylitis in children after antibiotic treatment. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Blistering Distal Dactylitis
- What is being tested?
- Positive rapid GAS test and Negative rapid GAS test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 0-18 years
- Distal blistering dactylitis collected or not collected
- Positive rapid Group A Streptococcus test
- Informed consent signed by the parents
Who cannot join
- Subungual or pulp Whitlow
- Children not affiliated to the social security scheme
- Refusal by the parents to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Single-center prospective study to assess the clinical course of group A streptococcal blistering distal dactylitis in children after antibiotic treatment.
Read the 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.
- Conditions
- Blistering Distal Dactylitis
- Being tested
- Positive rapid GAS test, Negative rapid GAS test
- Keywords
- blistering distal dactylitis, Streptococcus pyogenes, antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive rapid GAS testProcedure or surgery
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 testProcedure or surgery
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Positive rapid Group A Streptococcus (GAS) test | Experimental | 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 Receives: Procedure: Positive rapid GAS test |
| Negative rapid GAS test | Active comparator | If case of negative rapid GAS test, usual care: local antiseptic or surgical intervention Receives: Procedure: Negative rapid GAS test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Secondary outcomes (11)
Frequency of distal blistering dactylitis with positive GAS test in children
Measured: 18 months
Frequency of collected distal blistering dactylitis with positive GAS test in children
Measured: 18 months
Frequency of germs involved in distal blistering dactylitis after pus culture in children
Measured: 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.
Measured: 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.
Measured: 18 months
Correlation between GAS test and pus culture in different age groups
Measured: 18 months
Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis
Measured: 18 months
Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis
Measured: 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
Measured: 18 months
Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment
Measured: 18 months
Number of Nail dystrophy at 3 months of follow-up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blistering Distal DactylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camille JUNG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Camille JUNG, Centre Hospitalier Intercommunal Creteil
- Investigators
- Camille Jung, MD, PhD, Principal investigator, CHIC Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624882
- Sponsor's protocol ID
- TAPPS
- Acronym
- TAPPS
- Status last verified
- Aug 2018
- First submitted
- 25 Nov 2015
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children
- ClinicalTrials.gov ID
- NCT02624882
- Acronym / sponsor ID
- TAPPS / TAPPS
- Conditions
- Blistering Distal Dactylitis
- Keywords
- blistering distal dactylitis, Streptococcus pyogenes, antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Camille JUNGUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive rapid Group A Streptococcus (GAS) test | Experimental | Procedure: Positive rapid GAS testIn 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 |
| Negative rapid GAS test | Active comparator | Procedure: Negative rapid GAS testIf case of negative rapid GAS test, usual care: local antiseptic or surgical intervention |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children 0-18 years
- Distal blistering dactylitis collected or not collected
- Positive rapid Group A Streptococcus test
- Informed consent signed by the parents
Key exclusion criteria (3 listed)
- Subungual or pulp Whitlow
- Children not affiliated to the social security scheme
- Refusal by the parents to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive rapid GAS testIf 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. | Procedure or surgery | Positive rapid Group A Streptococcus (GAS) test |
| Negative rapid GAS testUsual care | Procedure or surgery | Negative rapid GAS test |
Primary outcome
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
11 secondary outcomes
Frequency of distal blistering dactylitis with positive GAS test in children
Time frame: 18 months
Frequency of collected distal blistering dactylitis with positive GAS test in children
Time frame: 18 months
Frequency of germs involved in distal blistering dactylitis after pus culture in children
Time frame: 18 months
Sensitivity of GAS test compared to pus culture
Time frame: 18 months
Specificity of GAS test compared to pus culture
Time frame: 18 months
Correlation between GAS test and pus culture in different age groups
Time frame: 18 months
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
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
Comparison between the cost of antibiotics versus surgical or local treatments of positive GAS test distal blistering dactylitis in children
Time frame: 18 months
Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment
Time frame: 18 months
Number of Nail dystrophy at 3 months of follow-up
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille Jung, MD, PhD principal investigator
CHIC Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive rapid GAS test and Negative rapid GAS test in people with Blistering Distal Dactylitis, run by Camille JUNG at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate healed blistering distal dactylitis with positive GAS test after 10 days of antibiotherapy directed against streptococcus pyogenes (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.