ACUTE SINUSITISPhase 4MEASURENCT07732699
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
A Phase 4 study testing Amoxicillin and Amoxi Clavulanate in people with ACUTE SINUSITIS and Sinusitis, 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 a sinus infection (acute sinusitis). Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- ACUTE SINUSITIS, Sinusitis
- What is being tested?
- Amoxicillin and Amoxi 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2 years to <12 years.
- Clinical diagnosis of AS.
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
- Periorbital redness and/or swelling, proptosis, or swelling of the forehead
- Individuals who qualify for both the AS and AOM trials (to avoid dual enrollment) will be excluded from the AS trial.
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
- Not yet recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Douglas Opel, MD, 206-987-6894, 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 a sinus infection (acute sinusitis). 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 examine whether factors such as the severity of the child's illness or signs of allergies affect how well antibiotics work. The results will help guide better treatment decisions for children with sinus 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 sinusitis (AS). 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 assess whether symptoms suggestive of allergy (sneezing or itchy eyes) or more severe nasal findings (such as marked congestion or perinasal crusting) influence treatment response. 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 examine whether factors such as the severity of the child's illness and signs of allergies affect how well antibiotics work. The results will help guide better treatment decisions for children with sinus infections
- Conditions
- ACUTE SINUSITIS, Sinusitis
- Being tested
- Amoxicillin, Amoxi Clavulanate, Amoxicillin Placebo, Amoxicillin-Clavulanate Placebo
- Keywords
- Pediatric Sinusitis, Sinusitis
- Medical subject headings
- Sinusitis
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 AS, for the defined treatment duration.
Amoxi ClavulanateDrug
Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM or AS, 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 sinusitis (AS). 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 AS. Caregivers will complete daily electronic symptom diaries throughout the treatment period. Receives: Drug: Amoxi Clavulanate |
| Amoxicillin Placebo | Placebo comparator | Participants randomized to this arm will receive a matching oral placebo for the treatment of AS. 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 AS. 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 Pediatric Rhinosinusitis Symptom Scale (PRSS Version 2.0). PRSS scores range from 0 to 40, 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 posted29 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 (6)Papers the sponsor has linked to this study.
- Other trials for ACUTE SINUSITISStudies 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
- NCT07732699
- Sponsor's protocol ID
- STUDY26010103 (AS)
- 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
Wald ER, Applegate KE, Bordley C, Darrow DH, Glode MP, Marcy SM, Nelson CE, Rosenfeld RM, Shaikh N, Smith MJ, Williams PV, Weinberg ST; American Academy of Pediatrics. Clinical practice guideline for the diagnosis and management of acute bacterial sinusitis in children aged 1 to 18 years. Pediatrics. 2013 Jul;132(1):e262-80. doi: 10.1542/peds.2013-1071.
PubMed 23796742Varni 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 14616041Varni 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 20730626Shaikh N, Hoberman A, Shope TR, Jeong JH, Kurs-Lasky M, Martin JM, Bhatnagar S, Muniz GB, Block SL, Andrasko M, Lee MC, Rajakumar K, Wald ER. Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial. JAMA. 2023 Jul 25;330(4):349-358. doi: 10.1001/jama.2023.10854.
PubMed 37490085Varni 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 15450120Shaikh N, Wald ER, Jeong JH, Kurs-Lasky M, Nash D, Pichichero ME, Kearney DH, Haralam MA, Bowen A, Flom LL, Hoberman A. Development and Modification of an Outcome Measure to Follow Symptoms of Children with Sinusitis. J Pediatr. 2019 Apr;207:103-108.e1. doi: 10.1016/j.jpeds.2018.11.016. Epub 2018 Dec 10.
PubMed 30545562