Acute Otitis Media (AOM)Phase 4MEASURENCT07730814
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
A Phase 4 study testing Amoxicillin and Amoxicillin-Clavulanate in people with Acute Otitis Media (AOM), run by Nader Shaikh at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Acute Otitis Media (AOM)
- What is being tested?
- Amoxicillin and Amoxicillin-Clavulanate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2026to 17 Mar 2032
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 months to <36 months.
- Clinical diagnosis of AOM.
Who cannot join
- 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
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- 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)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Bill Brinkman, MD, 513-636-2576, bill.brinkman@cchmc.org
- Not yet recruiting
University of Colorado, Denver
Denver, Colorado, 80204
Sean O'Leary, MD, 303-724-1582, sean.oleary@cuanschutz.edu
- Not yet recruiting
Duke University Hospital
Durham, North Carolina, 27705
Charles Wood, MD, 919-620-4772, charles.wood@duke.edu
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Nader Shaikh, MD, 412-692-8111, Nader.Shaikh@chp.edu
Nader Shaikh, MD
- Not yet recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Douglas Opel, MD, 2069876894, douglas.opel@seattlechildrens.org
About this study
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.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study designed to better understand whether the choice of antibiotic affects symptom burden in children with acute otitis media (AOM). Children enrolled in the study are randomly assigned to receive amoxicillin, amoxicillin-clavulanate, or a matching placebo. Neither the families nor the study team know which treatment a child is receiving during the study period. The primary objective is to compare average daily symptom severity across treatment groups using validated caregiver-reported symptom scales collected through daily electronic diaries. Analyses will account for baseline symptom severity and a combined fever/age category (temperature ≥38.5°C or age <12 months). The goal is to provide rigorous, comparative evidence on antibiotic use in this common pediatric infection to support more informed clinical decision-making and responsible antimicrobial prescribing. The study will also look at whether certain factors such as how sick the child is at the start, presence of fever, age, and how well antibiotics work. The results will help guide better treatment decisions for children with ear infections.
- Conditions
- Acute Otitis Media (AOM)
- Being tested
- Amoxicillin, Amoxicillin-Clavulanate, Amoxicillin Placebo, Amoxicillin-Clavulanate Placebo
- Keywords
- Ear Infection, AOM, Acute Otitis Media
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
Amoxicillin-ClavulanateDrug
Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
Amoxicillin PlaceboDrug
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
Amoxicillin-Clavulanate PlaceboDrug
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Active comparator | 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. Receives: Drug: Amoxicillin |
| Amoxicillin-Clavulanate | Active comparator | 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. Receives: Drug: Amoxicillin-Clavulanate |
| Amoxicillin Placebo | Placebo comparator | 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. Receives: Drug: Amoxicillin Placebo |
| Amoxicillin-Clavulanate Placebo | Placebo comparator | 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. Receives: Drug: Amoxicillin-Clavulanate Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 1-10
Secondary outcomes (2)
Safety Outcome: Diarrhea
Occurrence of diarrhea, defined as at least 3 watery stools in one day or at least 2 watery stools per day on two consecutive days.
Measured: Randomization through Day 10
Recurrence of Acute Sinusitis or Acute Otitis Media
Occurrence of one or more new episodes of clinically diagnosed acute sinusitis or acute otitis media following resolution of the index episode.
Measured: Days 11-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion18 Dec 2031 (estimated)
- Study completion17 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis Media (AOM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nader Shaikh
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Nader Shaikh, University of Pittsburgh
- Investigators
- Nader Shaikh, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730814
- Sponsor's protocol ID
- STUDY26010103 (AOM)
- Other IDs
- PLACER-2024C3-42497
- Acronym
- MEASURE
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26099233Hoberman 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.
PubMed 21226576Varni 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.
PubMed 15450120Varni 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.
PubMed 20730626Varni 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.
PubMed 14616041Shaikh 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.
PubMed 38961165Hum 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.
PubMed 31561959Lieberthal 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.
PubMed 23439909