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NCT07732699

Overview

NCT ID: NCT07732699
Lead Sponsor: Nader ShaikhOTHER
Official Title: Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
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 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.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Dec 18, 2031Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 1,100Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Jane Luce, MPHContact
lucej2@upmc.edu412-383-7853

Similar Studies

Participant Group/Arms

AmoxicillinActive 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.

Drug: Amoxicillin

Amoxicillin-ClavulanateActive 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.

Drug: Amoxi Clavulanate

Amoxicillin PlaceboPlacebo 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.

Drug: Amoxicillin Placebo

Amoxicillin-Clavulanate PlaceboPlacebo 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.

Drug: Amoxicillin-Clavulanate Placebo

Locations

University of Colorado, Denver

Denver, Colorado 80204, United States

Sean O'Leary, MDContact

sean.oleary@cuanschutz.edu303-724-1582

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