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

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ClinicalTrials.gov Identifier: NCT03264911
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborators:
Gertrude Von Meissner Foundation
Recherche et Développement des HUG
Société académique de Genève
Information provided by (Responsible Party):
Klara Posfay-Barbe, University Hospital, Geneva

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Group A Streptococcal Pharyngitis Drug: Amoxicillin or Placebo Phase 4

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  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 27, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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




Primary Outcome Measures :
  1. Non inferiority [ Time Frame: up to 1 month ]
    Duration of fever and other clinical signs/symptoms in not treated children versus treated


Secondary Outcome Measures :
  1. Number of consultations for pharyngitis [ Time Frame: 1 year ]
    To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms

  2. suppurative complications [ Time Frame: 1 year ]
    to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections

  3. non-suppurative complications [ Time Frame: 1 year ]
    to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections

  4. eradication [ Time Frame: 1 month ]
    to evaluate bacteriological eradication rates of the initial pathogen

  5. 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

  6. GAS strains [ Time Frame: 1 month ]
    to investigate the biology and genetic structure of GAS strains in Switzerland.



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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264911


Contacts
Contact: Klara Posfay-Barbe +4122372 5462 klara.posfaybarbe@hcuge.ch

Locations
Switzerland
Children's Hospital of Geneva (HUG) Recruiting
Geneva, GE, Switzerland, 1211
Contact: Klara M Posfay-Barbe, MD, MS    +41 22 372 5462    Klara.PosfayBarbe@hcuge.ch   
Principal Investigator: Klara M Posfay-Barbe, MD, MS         
Sponsors and Collaborators
Klara Posfay-Barbe
Gertrude Von Meissner Foundation
Recherche et Développement des HUG
Société académique de Genève
Investigators
Principal Investigator: Klara Posfay-Barbe Coordinator

Responsible Party: Klara Posfay-Barbe, Head of Pediatric Infectious Diseases, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03264911     History of Changes
Other Study ID Numbers: GASPARD
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Klara Posfay-Barbe, University Hospital, Geneva:
pharyngitis
amoxicillin

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents