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Study on Treatments for Ear Infections in Children

This study is looking at how well different treatments work for ear infections (acute otitis media or AOM) in children aged 6 months to under 3 years old. We want to see if antibiotics like amoxicillin or amoxicillin-clavulanate help children feel better compared to a placebo (a look-alike medicine with no active antibiotic). You or your child would be randomly assigned to one of these treatments. Neither you nor the study team will know which treatment your child is receiving. We will ask you to report your child's symptoms daily for 10 days to see how much their symptoms improve. This helps us understand the best ways to treat ear infections.

Study design
This is a multi-center, randomized, double-blind study with 1100 planned participants. Children will receive either amoxicillin, amoxicillin-clavulanate, or a matching placebo.
What's involved
Parents or caregivers will report their child's symptoms daily using an electronic diary for 10 days.
Compensation
Not stated in the trial record.
Follow-up
The main symptoms are measured daily for 10 days after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07730814

Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)

Not Yet Recruiting
PHASE4Ages 6–36InterventionalTreatment
Nader Shaikh
~1,100 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:AmoxicillinAmoxicillin-ClavulanateAmoxicillin PlaceboAmoxicillin-Clavulanate Placebo

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average Daily Symptom Burden
Measured over Days 1-10

Conditions

Acute Otitis Media (AOM)

Explore related trials

Acute otitis media

Where it's being run

5 sites across 5 states
Colorado1
North Carolina1
Ohio1
Pennsylvania1
Washington1

Study leadership

  • Nader Shaikh, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Jane Luce, MPH
[email protected]
412-383-7853
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Average Daily Symptom BurdenDays 1-10

    Symptom burden measured daily using the Acute Otitis Media Severity of Symptoms Scale (AOM-SOS Version 6.0). AOM-SOS scores range from 0 to 50, with higher scores indicating worse symptoms. Daily scores are averaged over Days 1-10