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NCT07878910
Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children
Conditions: Acute Otitis Media, AOM - Acute Otitis Media
Sex: All
Ages: 6 Months – 35 Months
Healthy volunteers: No
Phase: PHASE4
Enrollment: 219
Sponsor: Kuopio University Hospital
Location: Kuopio University Hospital Kuopio Northern Savonia
Summary
The goal of this trial is to compare amoxicillin to amoxicillin-clavulanate and to placebo in the treatment of acute middle ear infections in small children. It will also learn about the possible side effects of antibiotics as compared to placebo.
The main questions it aims to answer are:
* Does treatment with antibiotics, either amoxicillin or amoxicillin-clavulanate, shorten the duration of symptoms in children with acute ear infection and what is the balance between pros and cons of antibiotics?
Participants will:
Take one of the two antibiotics or a placebo every day for 7 days.
Eligibility Criteria
Inclusion Criteria:
* acute otitis media along the diagnostic criteria:
1. The child has acute symptoms, such as fever, ear pain, or respiratory symptoms
2. Tympanic membrane shows in otoscopy at least one of the following acute inflammatory signs:
* intense erythematous patches or streaks over full tympanic membrane
* bulging tympanic membrane 3. The presence of middle-ear effusion, established either by
* decreased or absent mobility in pneumatic otoscopy,
* flat tympanogram (B) or
* air-fluid interfaces behind full or bulging tympanic membrane
Exclusion Criteria:
* complicated AOM
* mastoiditis, facial palsy, inner ear infection
* spontaneous perforation of the tympanic membrane
* known allergy to aminopenicillins
* known severe allergy to other beta-lactam antibiotics
* antibiotic treatment for another infectious disease, present or during two preceding weeks
* tympanostomy tube or chronic perforation of the tympanic membrane
* anatomic defect or anomaly affecting the susceptibility to AOM
* immune defect, either primary or secondary
* severe chronic kidney disease
* known hearing defect
Source: ClinicalTrials.gov (NCT07878910). StuddyBuddy aggregates publicly available trial information.