| Registry | NCT07730814, acronym MEASURE |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 1100 (Estimated) |
| Sponsor | Nader Shaikh (Other); collaborators: Patient-Centered Outcomes Research Institute |
| Conditions | Acute Otitis Media (AOM) |
| Interventions | Amoxicillin, Amoxicillin-Clavulanate, Amoxicillin Placebo, Amoxicillin-Clavulanate Placebo (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2031-12-18 (estimated), completion 2032-03-17 (estimated), first posted 2026-07-28, last updated 2026-10-20 |
| Locations | 5 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Otitis Media (AOM) All trials of Amoxicillin All trials of Amoxicillin-Clavulanate
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Amoxicillin | Active comparator | Drug: 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. |
| Amoxicillin-Clavulanate | Active comparator | Drug: 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. |
| Amoxicillin Placebo | Placebo comparator | Drug: 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. |
| Amoxicillin-Clavulanate Placebo | Placebo comparator | Drug: 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. |
Sex: All, ages: 6 Months to 36 Months
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)
| Facility | City | Country | Status |
|---|---|---|---|
| University of Colorado, Denver | Denver, Colorado | United States | Not yet recruiting |
| Duke University Hospital | Durham, North Carolina | United States | Not yet recruiting |
| Cincinnati Children's Hospital | Cincinnati, Ohio | United States | Not yet recruiting |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania | United States | Recruiting |
| Seattle Children's Hospital | Seattle, Washington | United States | Not yet recruiting |