Antibiotics for Ear Infections
(MEASURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if antibiotics help children recover from acute otitis media, commonly known as an ear infection. Children will receive either amoxicillin, amoxicillin-clavulanate, or a placebo (a look-alike medicine with no active drug), and the allocation will remain unknown until the study concludes. Parents will track symptoms daily to assess how each treatment affects the child's recovery. The trial seeks children aged 6 months to under 36 months who have been diagnosed with an ear infection. The results will guide better treatment decisions for ear infections in children. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.
What is the safety track record for these treatments?
Previous studies have shown that amoxicillin is a safe choice for children with ear infections. Research found it rarely fails to improve the infection, with only about 2.2% of children experiencing this issue, suggesting it is generally well-tolerated.
Amoxicillin-clavulanate, a combination treatment, also works well but more often causes diarrhea, a common side effect. However, it effectively reduces symptoms and treatment failures in some cases. Doctors widely use and recommend both treatments, supported by extensive safety data.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they aim to tackle ear infections, specifically acute otitis media (AOM), with two well-known antibiotics: amoxicillin and amoxicillin-clavulanate. Unlike some treatments that might not address resistant bacteria effectively, amoxicillin-clavulanate combines amoxicillin with clavulanic acid, which helps overcome bacterial resistance by inhibiting certain enzymes. This combination could potentially offer a more robust defense against bacteria that have become resistant to standard amoxicillin alone, providing a more effective option for stubborn ear infections.
What evidence suggests that this trial's treatments could be effective for ear infections?
In this trial, participants will receive either amoxicillin or amoxicillin-clavulanate for ear infections. Research has shown that both medications effectively treat ear infections in children. High-dose amoxicillin remains the preferred choice for acute ear infections, helping most children recover. One study found that by day 14, about 93% of children taking amoxicillin had their symptoms resolve. Amoxicillin-clavulanate also proved effective, with about 87% of children improving. Both treatments generally outperform no antibiotics or a placebo, making them reliable options for treating ear infections.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either amoxicillin, amoxicillin-clavulanate, or a placebo for the treatment of acute otitis media. Caregivers complete daily electronic symptom diaries.
Follow-up
Participants are monitored for recurrence of acute sinusitis or acute otitis media following resolution of the index episode.
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?
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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
Citations
Acute otitis media: making sense of recent guidelines on ...
High-dose amoxicillin (80 to 90 mg/kg/d divided twice daily) remains the drug of choice for treatment of acute otitis media despite increasing antimicrobial ...
2.
healio.com
healio.com/news/pediatrics/20240212/amoxicillin-remains-effective-against-ear-infections-small-study-showsAmoxicillin remains effective against ear infections, small ...
Amoxicillin remains effective against acute otitis media, according to the results of a small study published in the Journal of the ...
3.
researchexperts.utmb.edu
researchexperts.utmb.edu/en/publications/amoxicillin-middle-ear-fluid-penetration-and-pharmacokinetics-in-/Amoxicillin middle ear fluid penetration and ...
MEF bacterial culture was positive in 23 of 40 ears (57.5%) before treatment with amoxicillin (40 mg/kg/day) and was still positive in 4 of 38 ears (10.5%) ...
4.
scholarlyexchange.childrensmercy.org
scholarlyexchange.childrensmercy.org/cgi/viewcontent.cgi?article=1073&context=clinical-critically-appraised-topicsAcute Otitis Media: Low Dose Versus High Dose Amoxicillin
Minimal evidence exists on outcomes of lower doses versus higher doses. Only one cohort study on patients with AOM and one RCT on patients ...
Is treatment of acute otitis media with once-a-day amoxicillin ...
AOM had resolved in 82% of group I and 68% of group II. Groups showed no significant differences in persistence of middle ear effusion; 39% in group I and 24% ...
Acute otitis media in adults
High doses of amoxicillin are effective against most penicillin-non-susceptible S. pneumoniae isolates in AOM since these typically display only ...
Antibiotic treatment of acute and recurrent otitis media ... - PMC
The amoxicillin-clavulanic acid is only recommended when there is a risk of infection by β-lactamase-producing microorganisms. This strategy ...
8.
dig.pharmacy.uic.edu
dig.pharmacy.uic.edu/faqs/2022-2/december-2022-faqs/what-evidence-supports-the-recommendation-for-high-dose-amoxicillin-in-children-with-acute-otitis-media/What evidence supports the recommendation for high-dose ...
The AAP recommends high-dose amoxicillin (eg, 80 to 90 mg/kg/day divided into 2 doses) in children who are not penicillin-allergic, do not have concurrent ...
Shortened Antimicrobial Treatment for Acute Otitis Media in ...
Clinical failure was observed in a greater percentage of children treated with amoxicillin–clavulanate for 5 days than of those treated for 10 ...
Otitis Media: Practice Essentials, Background, ...
Amoxicillin is the antibiotic of choice unless the child received it within 30 days, has concurrent purulent conjunctivitis, or is allergic to ...
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