Recruiting
Phase 4

Amoxicillin & Amoxicillin-Clavulanate

Sponsor:

Nader Shaikh

Code:

NCT07730814

Conditions

Acute Otitis Media (AOM)

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Amoxicillin

Amoxicillin-Clavulanate

Amoxicillin Placebo

Amoxicillin-Clavulanate Placebo

Study Details

Brief 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)

Study ID

NCT07730814

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Mar 17, 2032

Anticipated

Primary completion date

Dec 18, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Inclusion Criteria

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

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
  • 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)

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Amoxicillin

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

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.

Amoxicillin Placebo

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

Amoxicillin-Clavulanate Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jane Luce, MPH

412-383-7853lucej2@upmc.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Nader Shaikh, MD

412-692-8111Nader.Shaikh@chp.edu

Principal Investigator:

Nader Shaikh, MD

More Information

Sponsor

Nader Shaikh

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Ear Infection
  • AOM
  • Acute Otitis Media

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Nader Shaikh on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.