Acute Otitis Media | Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
Acute Otitis Media research study
What is the primary objective of this study?
The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfactory clinical outcome. This is a Phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial in 600 children aged 6 through 23 months comparing the efficacy of consistent reduced-duration antimicrobial treatment (5 days) with that of consistent standard-duration treatment (10 days) for each episode of AOM developing during a single respiratory season (October 1 through May 31).
Who is eligible to participate?
Inclusion Criteria: 1. Aged 6 through 23 months 2. Have evidence of AOM defined as: - recent (within 48 hours) onset of signs and symptoms as described in the Acute Otitis Media - Severity of Symptoms (AOM-SOS) Scale AND a score of ≥3 at the time of enrollment on the AOM-SOS scale - middle ear effusion evidenced by the presence of at least 2 of the following: - decreased or absent mobility of the tympanic membrane - yellow or white discoloration of the tympanic membrane - opacification of the tympanic membrane AND - acute inflammation evidenced by one of the following: - 1+ bulging of the tympanic membrane with either intense erythema or otalgia - 2+ or 3+ bulging of the tympanic membrane 3. Has received at least 2 doses of pneumococcal conjugate vaccine 4. Parent has provided informed consent Exclusion Criteria: 1. Toxic appearance [capillary refill >3 seconds, systolic blood pressure <60 mm Hg]; 2. Inpatient hospitalization 3. Clinical or anatomical characteristics that might obscure response to treatment (tympanostomy tubes in place, cleft palate, or Down syndrome) 4. Sensorineural hearing loss (unilateral or bilateral) 5. Serious underlying systemic problems that might obscure response to infection (cystic fibrosis, neoplasm, juvenile diabetes) 6. Concomitant infection that would preclude evaluation of the response of the child's AOM to study product (pneumonia, periorbital cellulitis) 7. Acute wheezing exacerbation which may require treatment with systemic corticosteroids 8. Known renal or hepatic dysfunction or insufficiency 9. History of amoxicillin-clavulanate-associated cholestatic jaundice 10. Immune dysfunction or receipt of immunosuppressive therapy; chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease) 11. Co-medications (systemic corticosteroids, more than one dose of systemic antimicrobial therapy within 96 hours, receipt of any investigational drug or vaccine within 30 days) 12. Hypersensitivity to penicillin, amoxicillin or amoxicillin-clavulanate, or phenylketonuria or known hypersensitivity to aspartame 13. Unable to complete study, or no access to phone 14. Previously enrolled in this study or currently enrolled in another study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Otitis Media
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Amoxicillin-Clavulanate, 10 daysAmoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-10
Drug:Amoxicillin-Clavulanate, 5 daysAmoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-5 Plus Placebo Days 6-10
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Amoxicillin-Clavulanate, 10 daysamoxicillin-clavulanate, 90/6.4 mg/kg/day, 2 divided doses, 10 days
Amoxicillin-Clavulanate, 5 daysamoxicillin-clavulanate, 90/6.4 mg/kg/day, 2 divided doses, 5 days plus placebo, 2 divided doses, 5 days
Start Date: January 2012
Completed Date: October 2015
Phase: Phase 2
Primary Outcome: The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM
Secondary Outcome: The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit
Study sponsors, principal investigator, and references
Principal Investigator: Alejandro Hoberman, MD
Lead Sponsor: Alejandro Hoberman
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)