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Group A Pharyngitis in Children: The GASPARD Study

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03264911
Acronym
GASPARD
Enrollment
360
Registered
2017-08-29
Start date
2017-01-27
Completion date
2018-12-31
Last updated
2017-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group A Streptococcal Pharyngitis

Keywords

pharyngitis, amoxicillin

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.

Interventions

DRUGAmoxicillin or Placebo

Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment

Sponsors

Gertrude Von Meissner Foundation
CollaboratorOTHER
Recherche et Développement des HUG
CollaboratorUNKNOWN
Société académique de Genève
CollaboratorUNKNOWN
Klara Posfay-Barbe
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial

Eligibility

Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Non inferiorityup to 1 monthDuration of fever and other clinical signs/symptoms in not treated children versus treated

Secondary

MeasureTime frameDescription
GAS strains1 monthto investigate the biology and genetic structure of GAS strains in Switzerland.
Number of consultations for pharyngitis1 yearTo evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms
co-infectionsat inclusionto discover if respiratory viruses are detected as co-infections in children with GAS pharyngitis upon initial presentation and during a recurrent episode
non-suppurative complications1 yearto evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections
eradication1 monthto evaluate bacteriological eradication rates of the initial pathogen
suppurative complications1 yearto evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections

Countries

Switzerland

Contacts

Primary ContactKlara Posfay-Barbe
klara.posfaybarbe@hcuge.ch+4122372 5462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026