<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03264911</url>
  </required_header>
  <id_info>
    <org_study_id>GASPARD</org_study_id>
    <nct_id>NCT03264911</nct_id>
  </id_info>
  <brief_title>Group A Pharyngitis in Children: The GASPARD Study</brief_title>
  <acronym>GASPARD</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klara Posfay-Barbe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gertrude Von Meissner Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Recherche et Développement des HUG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Société académique de Genève</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the necessity to treat with antibiotics GAS pharyngitis in children in Switzerland.&#xD;
      The null hypothesis is that antibiotic treatment is not necessary for GAS pharyngitis in this&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All children between 3 -15 years old with clinical symptoms suggestive of pharyngitis (Mc&#xD;
      Isaac score ≥3) and a microbiological test (rapid antigen detection) positive for group A&#xD;
      Streptococcus (GAS) will be included in the study. In order to assess the strain of GAS as&#xD;
      well as to identify co-infected children with respiratory virus, a throat culture and a&#xD;
      nasopharyngeal swab will be performed, as well as a standard questionnaire and a standard&#xD;
      physical exam. At this time, children will be randomized to either 6 days of amoxicilline or&#xD;
      6 days of placebo treatment. During the treatment period, the investigators will ask the&#xD;
      parents/legal guardians of the patients to pay close attention to the evolution of the&#xD;
      symptoms (fever, pain, exudates…) as well as the treatment's adverse event, and to report&#xD;
      their presence or absence in a dairy form. At day three after initiation of treatment, a&#xD;
      standardized clinical evaluation will be completed by phone to identify if the patient still&#xD;
      has symptoms of pharyngitis or signs of suppurative complications. One month after the&#xD;
      inclusion in the study, a throat culture, a standardized questionnaire as well as a clinical&#xD;
      evaluation will be performed to identify if the patient has or had signs of non-suppurative&#xD;
      complications and non-resolving infection. Six month and one year after inclusion, a phone&#xD;
      call will evaluate the possible relapses, recurrences and complications of GAS infection with&#xD;
      a standardized questionnaire. GAS strains will be analyzed to identify their unique&#xD;
      fingerprint and viral coinfections will be reported to possibly identify cofactors for&#xD;
      increased complication rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non inferiority</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Duration of fever and other clinical signs/symptoms in not treated children versus treated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of consultations for pharyngitis</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>suppurative complications</measure>
    <time_frame>1 year</time_frame>
    <description>to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>non-suppurative complications</measure>
    <time_frame>1 year</time_frame>
    <description>to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eradication</measure>
    <time_frame>1 month</time_frame>
    <description>to evaluate bacteriological eradication rates of the initial pathogen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>co-infections</measure>
    <time_frame>at inclusion</time_frame>
    <description>to discover if respiratory viruses are detected as co-infections in children with GAS pharyngitis upon initial presentation and during a recurrent episode</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAS strains</measure>
    <time_frame>1 month</time_frame>
    <description>to investigate the biology and genetic structure of GAS strains in Switzerland.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Group A Streptococcal Pharyngitis</condition>
  <arm_group>
    <arm_group_label>amoxicillin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin or Placebo</intervention_name>
    <description>Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment</description>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_label>amoxicillin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3 -15 years old&#xD;
&#xD;
          -  Clinical symptoms suggestive of pharyngitis with MC Isaac score ≥3&#xD;
&#xD;
          -  Rapid-antigen detection test (RADT) positive for GAS-&#xD;
&#xD;
          -  Signed informed parental/patient consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to B-lactams&#xD;
&#xD;
          -  concomitant disease which must be treated with antibiotics&#xD;
&#xD;
          -  chronic disease-Immunocompromised&#xD;
&#xD;
          -  Antibiotics within 72 h&#xD;
&#xD;
          -  history of ARF,scarlet fever,impetigo,acute glomerulonephritis&#xD;
&#xD;
          -  Family history of ARF&#xD;
&#xD;
          -  Complicated pharyngitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klara Posfay-Barbe</last_name>
    <role>Principal Investigator</role>
    <affiliation>Coordinator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Klara Posfay-Barbe</last_name>
    <phone>+4122372 5462</phone>
    <email>klara.posfaybarbe@hcuge.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children's Hospital of Geneva (HUG)</name>
      <address>
        <city>Geneva</city>
        <state>GE</state>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Klara M Posfay-Barbe, MD, MS</last_name>
      <phone>+41 22 372 5462</phone>
      <email>Klara.PosfayBarbe@hcuge.ch</email>
    </contact>
    <investigator>
      <last_name>Klara M Posfay-Barbe, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Klara Posfay-Barbe</investigator_full_name>
    <investigator_title>Head of Pediatric Infectious Diseases</investigator_title>
  </responsible_party>
  <keyword>pharyngitis</keyword>
  <keyword>amoxicillin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264911
org study id: GASPARD
nct id: NCT03264911
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Non inferiority
time frame: up to 1 month
description: Duration of fever and other clinical signs/symptoms in not treated children versus treated
measure: Number of consultations for pharyngitis
time frame: 1 year
description: To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms
measure: suppurative complications
time frame: 1 year
description: to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections
measure: non-suppurative complications
time frame: 1 year
description: to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections
measure: eradication
time frame: 1 month
description: to evaluate bacteriological eradication rates of the initial pathogen
measure: co-infections
time frame: at inclusion
description: to discover if respiratory viruses are detected as co-infections in children with GAS pharyngitis upon initial presentation and during a recurrent episode
measure: GAS strains
time frame: 1 month
description: to investigate the biology and genetic structure of GAS strains in Switzerland.
arm group label: amoxicillin
arm group type: Active Comparator
description: 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.
arm group label: Placebo arm
arm group type: Placebo Comparator
description: Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days.
intervention type: Drug
intervention name: Amoxicillin or Placebo
description: Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment
arm group label: Placebo arm
arm group label: amoxicillin
criteria: 
gender: All
minimum age: 3 Years
maximum age: 15 Years
healthy volunteers: No
last name: Klara Posfay-Barbe
role: Principal Investigator
affiliation: Coordinator
last name: Klara Posfay-Barbe
phone: +4122372 5462
email: klara.posfaybarbe@hcuge.ch
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Klara Posfay-Barbe
investigator title: Head of Pediatric Infectious Diseases
mesh term: Pharyngitis
mesh term: Amoxicillin
sharing ipd: Undecided