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

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Acute Otitis Media (AOM)

In brief

This study is being conducted at multiple hospitals and clinics to better understand whether antibiotics truly help children feel better when they have an ear infection (acute otitis media). Children in the study are randomly assigned (like flipping a coin) to receive either amoxicillin, amoxicillin-clavulanate, or a placebo (a look-alike medicine with no active antibiotic). Neither families nor study staff know which treatment the child is receiving during the study. The main goal is to compare how severe children's symptoms are each day while on these treatments. Parents or caregivers will report symptoms daily using a simple electronic diary. The study will also look at whether certain factors such as how sick the child is at the start, presence of fever, age, or how well antibiotics work. The results will help guide better treatment decisions for children with ear infections.

Key facts

Study ID

NCT07730814

Run by

Nader Shaikh

People needed

1100

Starts

2026-10-01

Expected to finish

2032-03-17

Last updated by the study team

2026-07-28

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 is running

• University of Colorado, Denver — Denver, Colorado, United States
• Duke University Hospital — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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