Comparing Antibiotics and Placebo for Ear Infections in Toddlers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind study in which children aged 6 to less than 36 months with acute otitis media receive either amoxicillin, amoxicillin-clavulanate, or a matching placebo. Families and investigators are unaware of the assignment to prevent bias, and daily caregiver-reported symptom diaries track symptom severity. The primary goal is to compare average daily symptom burden across the three treatment groups, adjusting for initial illness severity and fever/age factors. Results aim to inform antimicrobial prescribing decisions for pediatric ear infections and support more targeted use of antibiotics. Secondary analyses will explore whether baseline symptoms, fever, age, or antibiotic response influence outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Age 6 months to \<36 months.
* Clinical diagnosis of AOM.

Exclusion Criteria

* Known allergy or other contraindication to oral amoxicillin or clavulanate
* Prior use of systemic antibiotics in the last 7 days
* History of renal impairment
* History of hepatic impairment
* Phenylketonuria or allergy to aspartame
* History of craniofacial abnormalities
* Concurrent bacterial infection requiring systemic antibiotic therapy (e.g., pneumonia, streptococcal pharyngitis)
* Ill appearance, systemic toxicity, or immunodeficiency
* Incomplete pneumococcal vaccination, defined as receipt of fewer than three doses of a pneumococcal conjugate vaccine
* Parent or caregiver unable to complete study surveys in English or Spanish
* Previous randomization into either MEASURE trial within the last 6 months
* Mastoiditis
* Conjunctivitis
* Temperature ≥39°C and AOM-SOS score ≥35
* Cochlear implants
* Spontaneous tympanic membrane perforation with otorrhea at presentation (participants who develop perforation and otorrhea after consent remain eligible)

Where it's running

• UPMC Children's Hospital of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting
• University of Colorado, Denver
  Denver, Colorado, United States Not yet recruiting
• Duke University Hospital
  Durham, North Carolina, United States Not yet recruiting
• Cincinnati Children's Hospital
  Cincinnati, Ohio, United States Not yet recruiting
• Seattle Children's Hospital
  Seattle, Washington, United States Not yet recruiting

Study contacts

• Principal investigator: Nader Shaikh, MD — University of Pittsburgh
• Study coordinator: Jane Luce, MPH
• Email: lucej2@upmc.edu
• Phone: 412-383-7853

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.