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

NCT07730814 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2026-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Acute Otitis Media (AOM)

Interventions

DRUG

Amoxicillin

Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.

DRUG

Amoxicillin-Clavulanate

Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.

DRUG

Amoxicillin Placebo

Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms

DRUG

Amoxicillin-Clavulanate Placebo

Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Nader Shaikh

    lead OTHER

Principal Investigators

  • Nader Shaikh, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2031-12-18
Completion
2032-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730814 on ClinicalTrials.gov