Group A Pharyngitis in Children: The GASPARD Study

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2018

Detailed Description

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.

Interventions

  • Drug: Amoxicillin or Placebo
    • Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment

Arms, Groups and Cohorts

  • Active Comparator: amoxicillin
    • 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.
  • Placebo Comparator: Placebo arm
    • Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days.

Clinical Trial Outcome Measures

Primary Measures

  • Non inferiority
    • Time Frame: up to 1 month
    • Duration of fever and other clinical signs/symptoms in not treated children versus treated

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Klara Posfay-Barbe
  • Collaborator
    • Gertrude Von Meissner Foundation
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Klara Posfay-Barbe, Head of Pediatric Infectious Diseases – University Hospital, Geneva
  • Overall Official(s)
    • Klara Posfay-Barbe, Principal Investigator, Coordinator
  • Overall Contact(s)
    • Klara Posfay-Barbe, +4122372 5462, klara.posfaybarbe@hcuge.ch

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