NCT03264911

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

August 15, 2017

Last Update Submit

August 28, 2017

Conditions

Group A Streptococcal Pharyngitis

Keywords

pharyngitisamoxicillin

Outcome Measures

Primary Outcomes (1)

  • Non inferiority

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

    up to 1 month

Secondary Outcomes (6)

  • Number of consultations for pharyngitis

    1 year

  • suppurative complications

    1 year

  • non-suppurative complications

    1 year

  • eradication

    1 month

  • co-infections

    at inclusion

  • +1 more secondary outcomes

Study Arms (2)

amoxicillin

ACTIVE COMPARATOR

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.

Drug: Amoxicillin or Placebo

Placebo arm

PLACEBO COMPARATOR

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

Drug: Amoxicillin or Placebo

Interventions

Amoxicillin or PlaceboDRUG

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

Placebo armamoxicillin

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Geneva (HUG)

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related Publications (1)

  • Gualtieri R, Verolet C, Mardegan C, Papis S, Loevy N, Asner S, Rohr M, Llor J, Heininger U, Lacroix L, Pittet LF, Posfay-Barbe KM. Amoxicillin vs. placebo to reduce symptoms in children with group A streptococcal pharyngitis: a randomized, multicenter, double-blind, non-inferiority trial. Eur J Pediatr. 2024 Nov;183(11):4773-4782. doi: 10.1007/s00431-024-05705-1. Epub 2024 Aug 31.

    PMID: 39215861DERIVED

MeSH Terms

Conditions

Pharyngitis

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Klara Posfay-Barbe

    Coordinator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Klara Posfay-Barbe

CONTACT

+4122372 5462klara.posfaybarbe@hcuge.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Pediatric Infectious Diseases

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 29, 2017

Study Start

January 27, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

CH(1)