Group A Pharyngitis in Children: The GASPARD Study (GASPARD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Group A Streptococcal Pharyngitis
• Intervention / Treatment: Drug: Amoxicillin or Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Klara Posfay-Barbe; Phone Number: +4122372 5462; Email: klara.posfaybarbe@hcuge.ch

Study Locations

• Switzerland
  • GE
    • Geneva, GE, Switzerland, 1211
      • Recruiting
      • Children's Hospital of Geneva (HUG)
      • Contact: Klara M Posfay-Barbe, MD, MS; Phone Number: +41 22 372 5462; Email: Klara.PosfayBarbe@hcuge.ch
      • Principal Investigator: Klara M Posfay-Barbe, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Amoxicillin or Placebo; Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment
Placebo Comparator: Placebo arm; Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days.	Drug: Amoxicillin or Placebo; Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Klara Posfay-Barbe
• Collaborators: Gertrude Von Meissner Foundation; Recherche et Développement des HUG; Société académique de Genève
• Investigators: Principal Investigator: Klara Posfay-Barbe, Coordinator

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: pharyngitis; amoxicillin
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: GASPARD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No