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Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis) (MEASURE)

23. juli 2026 opdateret af: Nader Shaikh
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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1100

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater, 80204
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Duke University Hospital
        • Kontakt:
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati Children's Hospital
        • Kontakt:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC Children's Hospital of Pittsburgh
        • Kontakt:
    • Washington
      • Seattle, Washington, Forenede Stater, 98105

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age 2 years to <12 years.
  • Clinical diagnosis of AS.

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
  • 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
  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Amoxicillin
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.
Medicin: Amoxicillin
Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AS, for the defined treatment duration.
Aktiv komparator: Amoxicillin-Clavulanate
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.
Medicin: Amoxi Clavulanate
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.
Placebo komparator: Amoxicillin Placebo
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.
Medicin: Amoxicillin Placebo
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
Placebo komparator: Amoxicillin-Clavulanate Placebo
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.
Medicin: Amoxicillin-Clavulanate Placebo
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average Daily Symptom Burden
Tidsramme: Days 1-10
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
Days 1-10

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety Outcome: Diarrhea
Tidsramme: Randomization through Day 10
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.
Randomization through Day 10
Recurrence of Acute Sinusitis or Acute Otitis Media
Tidsramme: Days 11-90
Occurrence of one or more new episodes of clinically diagnosed acute sinusitis or acute otitis media following resolution of the index episode.
Days 11-90

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nader Shaikh

Samarbejdspartnere

Patient-Centered Outcomes Research Institute

Efterforskere

  • Ledende efterforsker: Nader Shaikh, MD, University of Pittsburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

18. december 2031

Studieafslutning (Anslået)

17. marts 2032

Datoer for studieregistrering

Først indsendt

23. juli 2026

Først indsendt, der opfyldte QC-kriterier

23. juli 2026

Først opslået (Faktiske)

29. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY26010103 (AS)
  • PLACER-2024C3-42497 (Andet bevillings-/finansieringsnummer: PCORI)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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