Group A Pharyngitis in Children: The GASPARD Study

Study Overview
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Brief Summary
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Evaluate the necessity to treat with antibiotics GAS pharyngitis in children in Switzerland. The null hypothesis is that antibiotic treatment is not necessary for GAS pharyngitis in this population.

Detailed Description
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All children between 3 -15 years old with clinical symptoms suggestive of pharyngitis (Mc Isaac score ≥3) and a microbiological test (rapid antigen detection) positive for group A Streptococcus (GAS) will be included in the study. In order to assess the strain of GAS as well as to identify co-infected children with respiratory virus, a throat culture and a nasopharyngeal swab will be performed, as well as a standard questionnaire and a standard physical exam. At this time, children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment. During the treatment period, the investigators will ask the parents/legal guardians of the patients to pay close attention to the evolution of the symptoms (fever, pain, exudates…) as well as the treatment's adverse event, and to report their presence or absence in a dairy form. At day three after initiation of treatment, a standardized clinical evaluation will be completed by phone to identify if the patient still has symptoms of pharyngitis or signs of suppurative complications. One month after the inclusion in the study, a throat culture, a standardized questionnaire as well as a clinical evaluation will be performed to identify if the patient has or had signs of non-suppurative complications and non-resolving infection. Six month and one year after inclusion, a phone call will evaluate the possible relapses, recurrences and complications of GAS infection with a standardized questionnaire. GAS strains will be analyzed to identify their unique fingerprint and viral coinfections will be reported to possibly identify cofactors for increased complication rates.

Official Title
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Group A Streptococcal Pharyngitis: Six Days Amoxicillin, oR Six Days Placebo in Children Between 3 and 15 Years Old:a Randomized, Double Blinded, Multicentred, Non-inferiority Trial

Conditions
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Group A Streptococcal Pharyngitis

Intervention / Treatment
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* Drug: Amoxicillin or Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 -15 years old Clinical symptoms suggestive of pharyngitis with MC Isaac score ≥3 Rapid-antigen detection test (RADT) positive for GAS- Signed informed parental/patient consent form Exclusion Criteria: Hypersensitivity to B-lactams concomitant disease which must be treated with antibiotics chronic disease-Immunocompromised Antibiotics within 72 h history of ARF,scarlet fever,impetigo,acute glomerulonephritis Family history of ARF Complicated pharyngitis

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: amoxicillin<br>Children will be randomized to receive, after consent to the study, an antibiotic (amoxicillin approximately 50 mg/kg/day) orally, twice a day for 6 days. | Drug: Amoxicillin or Placebo<br>* Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment<br>|
| Placebo Comparator: Placebo arm<br>Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days. | Drug: Amoxicillin or Placebo<br>* Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non inferiority | Duration of fever and other clinical signs/symptoms in not treated children versus treated | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of consultations for pharyngitis | To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms | 1 year | 
| suppurative complications | to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections | 1 year | 
| non-suppurative complications | to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections | 1 year | 
| eradication | to evaluate bacteriological eradication rates of the initial pathogen | 1 month | 
| co-infections | to discover if respiratory viruses are detected as co-infections in children with GAS pharyngitis upon initial presentation and during a recurrent episode | at inclusion | 
| GAS strains | to investigate the biology and genetic structure of GAS strains in Switzerland. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharyngitis, amoxicillin