Topical or oral antibiotics for children with acute otitis media presenting with ear discharge? - PLOTS

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht0 sites350 target enrollmentJune 27, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Enrollment: 350
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

June 27, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht

•Children aged 6 months to 12 years whose parents are consulting the GP with AOM and ear discharge in one or both ears (\= 7 days duration) and either parent\-reported ear pain in the previous 24 hours or fever (child’s body temperature of \= 38\.0°C in the previous 24 hours as reported by parents or as measured by the GP during consultation) or both.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 350
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Children will be excluded from participation if they
•1\. are systemically very unwell and requires immediate oral antibiotics or immediate hospitalization (e.g. child has signs and symptoms of serious illness and/or complications such as mastoiditis/meningitis);
•2\. are at high risk of serious complications including children with known immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial malformation such as cleft palate, children with Down syndrome, previous ear surgery other than grommet insertion;
•3\. have grommets in place;
•4\. have a pre\-existing perforation of the eardrum;
•5\. had an prior AOM episode (with or without ear discharge) in previous 28 days;
•6\. used oral antibiotics or topical antibiotics in previous 2 weeks;
•7\. have a known allergy or sensitivity to oral amoxicillin or hydrocortisone\-bacitracin\-colistin;
•8\. have already participated in this trial.