Group A Pharyngitis in Children: The GASPARD Study

Group A Streptococcal Pharyngitis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264911
• Other study ID #: GASPARD
• Status: Recruiting
• Phase: Phase 4
• First received: August 15, 2017
• Last updated: August 28, 2017
• Start date: January 27, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2017
• Source: University Hospital, Geneva
• Contact: Klara Posfay-Barbe
• Phone: +4122372 5462
• Email: klara.posfaybarbe[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Group A Streptococcal Pharyngitis
• Pharyngitis

Intervention

Drug:
• Amoxicillin or Placebo
Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment

Locations

Country	Name	City	State
Switzerland	Children's Hospital of Geneva (HUG)	Geneva	GE

Sponsors (4)

Lead Sponsor	Collaborator
Klara Posfay-Barbe	Gertrude Von Meissner Foundation, Recherche et Développement des HUG, Société académique de Genève

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non inferiority	Duration of fever and other clinical signs/symptoms in not treated children versus treated	up to 1 month
Secondary	Number of consultations for pharyngitis	To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms	1 year
Secondary	suppurative complications	to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections	1 year
Secondary	non-suppurative complications	to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections	1 year
Secondary	eradication	to evaluate bacteriological eradication rates of the initial pathogen	1 month
Secondary	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	at inclusion
Secondary	GAS strains	to investigate the biology and genetic structure of GAS strains in Switzerland.	1 month