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

23 juli 2026 uppdaterad av: 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 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

1100

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Colorado
      • Denver, Colorado, Förenta staterna, 80204
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27705
        • Duke University Hospital
        • Kontakt:
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45229
        • Cincinnati Children's Hospital
        • Kontakt:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • UPMC Children's Hospital of Pittsburgh
        • Kontakt:
        • Huvudutredare:
          • Nader Shaikh, MD
    • Washington
      • Seattle, Washington, Förenta staterna, 98105

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria

  • Age 6 months to <36 months.
  • Clinical diagnosis of AOM.

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
  • 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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Average Daily Symptom Burden
Tidsram: Days 1-10
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Safety Outcome: Diarrhea
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Nader Shaikh

Samarbetspartners

Patient-Centered Outcomes Research Institute

Utredare

  • Huvudutredare: Nader Shaikh, MD, University of Pittsburgh

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

18 december 2031

Avslutad studie (Beräknad)

17 mars 2032

Studieregistreringsdatum

Först inskickad

23 juli 2026

Först inskickad som uppfyllde QC-kriterierna

23 juli 2026

Första postat (Faktisk)

28 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY26010103 (AOM)
  • PLACER-2024C3-42497 (Annat bidrag/finansieringsnummer: PCORI)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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