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.
Inclusion Criteria
Exclusion Criteria
lucej2@upmc.edu412-383-7853
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.
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.
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.
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.
Denver, Colorado 80204, United States
sean.oleary@cuanschutz.edu303-724-1582
charles.wood@duke.edu919-620-4772
bill.brinkman@cchmc.org513-636-2576
Nader.Shaikh@chp.edu412-692-8111
douglas.opel@seattlechildrens.org2069876894
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
Acute Otitis Media (AOM) Therapy Trial in Young Children
Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children
Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Amoxicillin Clavulanate in Treatment of Acute Otitis Media