Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
MEASURE
2 other identifiers
interventional
1,100
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2026
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2031
Study Completion
Last participant's last visit for all outcomes
March 17, 2032
July 28, 2026
July 1, 2026
5.2 years
July 23, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Daily Symptom Burden
Symptom burden measured daily using the Acute Otitis Media Severity of Symptoms Scale (AOM-SOS Version 6.0). AOM-SOS scores range from 0 to 50, with higher scores indicating worse symptoms. Daily scores are averaged over Days 1-10
Days 1-10
Secondary Outcomes (2)
Safety Outcome: Diarrhea
Randomization through Day 10
Recurrence of Acute Sinusitis or Acute Otitis Media
Days 11-90
Study Arms (4)
Amoxicillin
ACTIVE COMPARATORParticipants 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.
Amoxicillin-Clavulanate
ACTIVE COMPARATORParticipants 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.
Amoxicillin Placebo
PLACEBO COMPARATORParticipants 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.
Amoxicillin-Clavulanate Placebo
PLACEBO COMPARATORParticipants 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 administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
Eligibility Criteria
You may qualify if:
- Age 6 months to \<36 months.
- Clinical diagnosis of AOM.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nader Shaikhlead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (5)
University of Colorado, Denver
Denver, Colorado, 80204, United States
Duke University Hospital
Durham, North Carolina, 27705, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (8)
Venekamp RP, Sanders SL, Glasziou PP, Del Mar CB, Rovers MM. Antibiotics for acute otitis media in children. Cochrane Database Syst Rev. 2015 Jun 23;2015(6):CD000219. doi: 10.1002/14651858.CD000219.pub4.
PMID: 26099233BACKGROUNDHoberman A, Paradise JL, Rockette HE, Shaikh N, Wald ER, Kearney DH, Colborn DK, Kurs-Lasky M, Bhatnagar S, Haralam MA, Zoffel LM, Jenkins C, Pope MA, Balentine TL, Barbadora KA. Treatment of acute otitis media in children under 2 years of age. N Engl J Med. 2011 Jan 13;364(2):105-15. doi: 10.1056/NEJMoa0912254.
PMID: 21226576BACKGROUNDVarni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. doi: 10.1186/1477-7525-2-55.
PMID: 15450120BACKGROUNDVarni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.
PMID: 20730626BACKGROUNDVarni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003 Nov-Dec;3(6):329-41. doi: 10.1367/1539-4409(2003)0032.0.co;2.
PMID: 14616041BACKGROUNDShaikh N, Lee MC, Kurs-Lasky M. Modification of an outcome measure to follow symptoms of children with acute otitis media. Pediatr Res. 2025 Feb;97(2):695-699. doi: 10.1038/s41390-024-03390-2. Epub 2024 Jul 3.
PMID: 38961165BACKGROUNDHum SW, Shaikh KJ, Musa SS, Shaikh N. Adverse Events of Antibiotics Used to Treat Acute Otitis Media in Children: A Systematic Meta-Analysis. J Pediatr. 2019 Dec;215:139-143.e7. doi: 10.1016/j.jpeds.2019.08.043. Epub 2019 Sep 24.
PMID: 31561959BACKGROUNDLieberthal AS, Carroll AE, Chonmaitree T, Ganiats TG, Hoberman A, Jackson MA, Joffe MD, Miller DT, Rosenfeld RM, Sevilla XD, Schwartz RH, Thomas PA, Tunkel DE. The diagnosis and management of acute otitis media. Pediatrics. 2013 Mar;131(3):e964-99. doi: 10.1542/peds.2012-3488. Epub 2013 Feb 25.
PMID: 23439909BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nader Shaikh, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 23, 2026
First Posted
July 28, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
December 18, 2031
Study Completion (Estimated)
March 17, 2032
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- De-identified IPD and supporting documentation will become available after publication of the primary study results and completion of PCORI's peer review and public release process, and no later than 12 months following publication of the primary results. Data and supporting documentation will remain available for at least seven years following study completion, consistent with PCORI policy requirements.
- Access Criteria
- Access to de-identified IPD and supporting documentation may be provided to qualified researchers for scientifically sound secondary research purposes, consistent with participant informed consent, institutional review board (IRB) requirements, and applicable laws and regulations. Requests may require submission of a research proposal, statistical analysis plan, and execution of a data use agreement. Data will be shared through a secure institutional or repository-based mechanism determined by the study team and sponsoring institution. Access decisions will be reviewed by the study investigators and/or designated data access committee in accordance with institutional and PCORI data sharing policies.
De-identified individual participant data (IPD) underlying the results reported in publications and the final study report, including relevant data dictionaries and metadata necessary to interpret the data, will be shared in accordance with PCORI's Policy for Data Management and Data Sharing. The shared data set will include the final cleaned and locked analyzable data set used for primary and secondary analyses reported from the study. Data will be de-identified in accordance with applicable federal and institutional privacy requirements, including the HIPAA Privacy Rule. Supporting documentation necessary to reproduce study findings and facilitate secondary analyses will also be made available.