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

Phase 4Not Yet RecruitingNCT07732699

Nader Shaikh1,100 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (5)

University of Colorado, Denver

Denver, Colorado, United States

Duke University Hospital

Durham, North Carolina, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Seattle Children's Hospital

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Time frame: Days 1-10

Secondary Outcomes

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.

Time frame: 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.

Time frame: Days 11-90