Which antibiotic works best for kids with sinus infections?
Official title: Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
Run by University of Pittsburgh · NCT07732699 · Data updated 2026-11-12
This study tests whether amoxicillin, amoxicillin-clavulanate, or a placebo help children with acute sinusitis feel better faster.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Enrollment | 1100 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 5 sites (Denver, Colorado and 4 other locations) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | December 18, 2031 |
| Study ends | March 17, 2032 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07732699 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 2 to under 12 years with a clinical diagnosis of acute sinusitis, without contraindications to study medicines or enrollment criteria.
✕Probably not a fit
Children with milder symptoms or those not responding to antibiotics may not experience a meaningful benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center, randomized, double-blind trial compares three treatment arms—amoxicillin, amoxicillin-clavulanate, and placebo—to determine how well each option reduces daily symptom burden in children with acute sinusitis. Caregivers record symptoms daily via an electronic diary, allowing comparison of average symptom severity across groups. The study also explores whether allergy signs or more severe nasal findings influence antibiotic response, to guide more informed prescribing practices. Enrollment is limited to children aged 2 to under 12 years without certain exclusion criteria, across several U.S. sites. Results aim to provide rigorous evidence to support antimicrobial stewardship in pediatric sinusitis management.
Why it matters
Potential benefit: If effective, the best-performing antibiotic could shorten illness and improve daily comfort for children with sinusitis.
How similar studies have gone: Previous antibiotic trials in pediatric sinusitis have produced mixed results; this study provides controlled, contemporary evidence with a placebo arm.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 2 years to \<12 years. * Clinical diagnosis of AS. 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 * 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.
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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.