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

Conditions

• Acute Otitis Media (AOM)

Eligibility Criteria

Sex

ALL

Age

6 Months - 36 Months

Healthy Volunteers

Not accepted

Interventions

• Amoxicillin — DRUG
  Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
• Amoxicillin-Clavulanate — DRUG
  Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
• Amoxicillin Placebo — DRUG
  Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
• Amoxicillin-Clavulanate Placebo — DRUG
  Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms

Study Details

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 Dates

First listed

Jul 28, 2026

Start date

Oct 1, 2026

Status verified

Jul 2026

Primary completion

Dec 18, 2031

Completion

Mar 17, 2032

Study Design

Enrollment

1,100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Amoxicillin
  Participants randomized to this arm will receive oral amoxicillin for the treatment of acute otitis media (AOM). Caregivers will complete daily electronic symptom diaries throughout the treatment period.
• Active Comparator: Amoxicillin-Clavulanate
  Participants randomized to this arm will receive oral amoxicillin-clavulanate for the treatment of AOM. Caregivers will complete daily electronic symptom diaries throughout the treatment period.
• Placebo Comparator: Amoxicillin Placebo
  Participants randomized to this arm will receive a matching oral placebo for the treatment of AOM. Caregivers will complete daily electronic symptom diaries throughout the treatment period.
• Placebo Comparator: Amoxicillin-Clavulanate Placebo
  Participants randomized to this arm will receive a matching oral placebo for the treatment of AOM. Caregivers will complete daily electronic symptom diaries throughout the treatment period.

Primary Outcome Measure

Average Daily Symptom Burden [ Time Frame: Days 1-10 ]

Central Contacts

• Jane Luce, MPH
  412-383-7853
  [email protected]

Locations (5)

Find similar trials in Denver, CO

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