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

Primary Purpose

Group A Streptococcal Pharyngitis

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Amoxicillin or Placebo
Sponsored by
Klara Posfay-Barbe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Group A Streptococcal Pharyngitis focused on measuring pharyngitis, amoxicillin

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Geneva (HUG)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

amoxicillin

Placebo arm

Arm 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.

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

Outcomes

Primary Outcome Measures

Non inferiority
Duration of fever and other clinical signs/symptoms in not treated children versus treated

Secondary Outcome Measures

Number of consultations for pharyngitis
To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms
suppurative complications
to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections
non-suppurative complications
to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections
eradication
to evaluate bacteriological eradication rates of the initial pathogen
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
GAS strains
to investigate the biology and genetic structure of GAS strains in Switzerland.

Full Information

First Posted
August 15, 2017
Last Updated
August 28, 2017
Sponsor
Klara Posfay-Barbe
Collaborators
Gertrude Von Meissner Foundation, Recherche et Développement des HUG, Société académique de Genève
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1. Study Identification

Unique Protocol Identification Number
NCT03264911
Brief Title
Group A Pharyngitis in Children: The GASPARD Study
Acronym
GASPARD
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Klara Posfay-Barbe
Collaborators
Gertrude Von Meissner Foundation, Recherche et Développement des HUG, Société académique de Genève

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Group A Streptococcal Pharyngitis
Keywords
pharyngitis, amoxicillin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
amoxicillin
Arm Type
Active Comparator
Arm 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 Title
Placebo arm
Arm Type
Placebo Comparator
Arm 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(s)
Amoxicillin or Placebo
Intervention Description
Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment
Primary Outcome Measure Information:
Title
Non inferiority
Description
Duration of fever and other clinical signs/symptoms in not treated children versus treated
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Number of consultations for pharyngitis
Description
To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms
Time Frame
1 year
Title
suppurative complications
Description
to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections
Time Frame
1 year
Title
non-suppurative complications
Description
to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections
Time Frame
1 year
Title
eradication
Description
to evaluate bacteriological eradication rates of the initial pathogen
Time Frame
1 month
Title
co-infections
Description
to discover if respiratory viruses are detected as co-infections in children with GAS pharyngitis upon initial presentation and during a recurrent episode
Time Frame
at inclusion
Title
GAS strains
Description
to investigate the biology and genetic structure of GAS strains in Switzerland.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klara Posfay-Barbe
Phone
+4122372 5462
Email
klara.posfaybarbe@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klara Posfay-Barbe
Organizational Affiliation
Coordinator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Geneva (HUG)
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klara M Posfay-Barbe, MD, MS
Phone
+41 22 372 5462
Email
Klara.PosfayBarbe@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Klara M Posfay-Barbe, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Group A Pharyngitis in Children: The GASPARD Study

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