Antibiotics for Ear Infections
(MEASURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Nader Shaikh, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for children with ear infections, including middle ear infection (acute otitis media) and swimmer's ear. Children who are otherwise healthy and able to take oral medicine can participate. Those with severe illness or allergies to study medicines may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Amoxicillin
- Amoxicillin-Clavulanate
Trial Overview
The study compares three treatments: amoxicillin, amoxicillin-clavulanate (both antibiotics), and a placebo (inactive medicine). Children are randomly assigned to one group, and neither families nor doctors know which treatment is given until the end of the study.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nader Shaikh
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
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