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

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ClinicalTrials.gov Identifier: NCT03264911
Recruitment Status : Unknown
Verified August 2017 by Klara Posfay-Barbe, University Hospital, Geneva.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE August 15, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date August 29, 2017
Actual Study Start Date  ICMJE January 27, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
Non inferiority [ Time Frame: up to 1 month ]
Duration of fever and other clinical signs/symptoms in not treated children versus treated
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group A Pharyngitis in Children: The GASPARD Study
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Group A Streptococcal Pharyngitis
Intervention  ICMJE Drug: Amoxicillin or Placebo
Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Amoxicillin or Placebo
  • Placebo Comparator: Placebo arm
    Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days.
    Intervention: Drug: Amoxicillin or Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 28, 2017)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03264911
Other Study ID Numbers  ICMJE GASPARD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Klara Posfay-Barbe, University Hospital, Geneva
Study Sponsor  ICMJE Klara Posfay-Barbe
Collaborators  ICMJE
  • Gertrude Von Meissner Foundation
  • Recherche et Développement des HUG
  • Société académique de Genève
Investigators  ICMJE
Principal Investigator: Klara Posfay-Barbe Coordinator
PRS Account University Hospital, Geneva
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP