Amoxicillin vs Placebo for Ear Infections in Young Children
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
Recruiting
Phase 4
Interventional Study
Acute Otitis Media (AOM)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 Months – 36 Months
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,100 (estimated)
- Sponsor
- Nader Shaikh · Other
Who this trial is looking for
This trial is looking for young children with ear infections. Participants will be randomly assigned to receive either amoxicillin, amoxicillin-clavulanate, or a placebo, and their symptoms will be tracked daily by their parents or caregivers.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 6 months to less than 36 months old.
- I have been diagnosed with an ear infection.
You may not be able to join if
- I have a known allergy to amoxicillin or clavulanate.
- I have taken antibiotics in the last 7 days.
- I have a history of kidney problems.
- I have a history of liver problems.
- I have phenylketonuria or an allergy to aspartame.
- I have craniofacial abnormalities.
- I have a current bacterial infection needing antibiotics.
- I look very ill or have a weakened immune system.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About 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 s…
Trial Locations
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Eligibility Criteria
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
* Phe…
Contacts