Title

Group A Pharyngitis in Children: The GASPARD 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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    360
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.
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.
Study Started
Jan 27
2017
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Aug 29
2017

Drug Amoxicillin or Placebo

Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment

amoxicillin Active Comparator

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 arm Placebo Comparator

Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days.

Criteria

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
No Results Posted