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

niversitair Medisch Centrum Utrecht0 个研究点目标入组 350 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

niversitair Medisch Centrum Utrecht