Back to search results

Comparing Treatments for Sinus and Ear Infections in Children

This study is comparing how well different treatments work for children aged 2 to 12 years with acute sinusitis (a sinus infection). You or your child would receive either amoxicillin, amoxicillin-clavulanate, or a placebo (a look-alike medicine without active antibiotic). Neither you nor the study staff will know which treatment is given. The main goal is to see how much children's symptoms improve each day over 10 days. We are looking for 1100 participants. The study status is currently unclear.

Study design
This is a multi-center, randomized, double-blind, placebo-controlled study with a planned enrollment of 1100 participants.
What's involved
Parents or caregivers will report symptoms daily using a simple electronic diary for 10 days.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 10 days, based on the primary endpoint time-frame.

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

NCT07732699

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

Not Yet Recruiting
PHASE4Ages 2–12InterventionalTreatment
Nader Shaikh
~1,100 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:AmoxicillinAmoxi 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 SINUSITIS
Sinusitis

Explore related trials

Acute Sinusitis

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

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age 2 years to \<12 years.
Clinical diagnosis of AS.

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
Periorbital redness and/or swelling, proptosis, or swelling of the forehead
Individuals who qualify for both the AS and AOM trials (to avoid dual enrollment) will be excluded from the AS trial.

What this trial measures

  • Average Daily Symptom BurdenDays 1-10

    Symptom burden measured daily using the Pediatric Rhinosinusitis Symptom Scale (PRSS Version 2.0). PRSS scores range from 0 to 40, with higher scores indicating worse symptoms. Daily scores are averaged over Days 1-10