Clinical trial NCT00643292: A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Amoxicillin/Clavulanate Potassium (Augmentin ES-600 Trademark) for the Treatment of Acute Otitis Media in Children Undergoing Diagnostic Tympanocentesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Media
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 902
Sex: ALL
Minimum age (years): 3
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections


Eligibility criteria: Inclusion Criteria:

Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included

Exclusion Criteria:

Patients with previously diagnosed disease of immune function, treatment with any systemic antibiotic within the previous 7 days, or cleft lip/palate or other anatomic abnormality predisposing to otitis media were excluded.

Primary outcomes:
measure: clinical response (cure or failure) in the Clinical Per Protocol population
timeFrame: Test of Cure (TOC) visit (Day 12-14)
Secondary outcomes:
measure: summary of baseline susceptibilities
timeFrame: Study endpoint
measure: clinical response (cure or failure) in the Clinical Per Protocol population
timeFrame: On-Treatment (OT) visit (Day 4-6)
measure: Laboratory abnormalities
timeFrame: Baseline and TOC visit
measure: bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population
timeFrame: TOC visit
measure: adverse events
timeFrame: Continuous
measure: clinical response (cure or failure) in all populations except the Clinical Per Protocol population
timeFrame: OT visit and TOC visit
measure: clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population
timeFrame: OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32)
measure: clinical response (cure or failure) in the Clinical Per Protocol population
timeFrame: LTFU visit
measure: clinical scores for the Clinical Per Protocol population
timeFrame: OT visit and TOC visit
measure: persistence of middle ear fluid for the Clinical Per Protocol population
timeFrame: TOC visit and LTFU visit
measure: audiologic response
timeFrame: LTFU visit
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Bellflower
country: United States
facility: Pfizer Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Newhall
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Pfizer Investigational Site
state: California
city: Bridgeport
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evanston
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Bardstown
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Payson
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Springville
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Vienna
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Independencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Recoleta
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
state: DN
city: Pärsti vald
country: Estonia
facility: Pfizer Investigational Site
state: Viljandimaa
city: Rakvere
country: Estonia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
city: Petach Tikva
country: Israel
facility: Pfizer Investigational Site
city: Tel Hashomer
country: Israel
facility: Pfizer Investigational Site
city: Chihuahua
country: Mexico
facility: Pfizer Investigational Site
city: Ciudad de Panama
country: Panama
facility: Pfizer Investigational Site
city: Chorzow
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: