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NCT00643292 Clinical Trial

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

Acute Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643292
Other study ID # A0661073
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2008
Last updated May 16, 2011
Start date January 2003
Est. completion date May 2004

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 902
Est. completion date May 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 48 Months
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• amoxicillin/clavulanate postassium (Augmentin ES-600)
amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
• azithromycin SR
azithromycin SR 60 mg/kg x 1 dose

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Unknown Buenos Aires
Argentina Pfizer Investigational Site Unknown Córdoba
Chile Pfizer Investigational Site Independencia Santiago
Chile Pfizer Investigational Site Recoleta Santiago
Chile Pfizer Investigational Site Santiago
Costa Rica Pfizer Investigational Site San Jose
Dominican Republic Pfizer Investigational Site Santo Domingo DN
Estonia Pfizer Investigational Site Pärsti vald Viljandimaa
Estonia Pfizer Investigational Site Rakvere
Estonia Pfizer Investigational Site Tallinn
Estonia Pfizer Investigational Site Tartu
Guatemala Pfizer Investigational Site Guatemala
Israel Pfizer Investigational Site Haifa
Israel Pfizer Investigational Site Jerusalem
Israel Pfizer Investigational Site Petach Tikva
Israel Pfizer Investigational Site Tel Hashomer
Mexico Pfizer Investigational Site Chihuahua
Panama Pfizer Investigational Site Ciudad de Panama
Poland Pfizer Investigational Site Chorzow
Poland Pfizer Investigational Site Lublin
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Smolensk
Slovakia Pfizer Investigational Site Kosice
Slovakia Pfizer Investigational Site Martin
United States Pfizer Investigational Site Bardstown Kentucky
United States Pfizer Investigational Site Bellflower California
United States Pfizer Investigational Site Bridgeport Connecticut
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Evanston Illinois
United States Pfizer Investigational Site Fountain Valley California
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Hartford Connecticut
United States Pfizer Investigational Site Huntington Beach California
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Newhall California
United States Pfizer Investigational Site Orange California
United States Pfizer Investigational Site Paramount California
United States Pfizer Investigational Site Payson Utah
United States Pfizer Investigational Site Pico Rivera California
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Springfield Kentucky
United States Pfizer Investigational Site Springville Utah
United States Pfizer Investigational Site Vienna Virginia

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Costa Rica,  Dominican Republic,  Estonia,  Guatemala,  Israel,  Mexico,  Panama,  Poland,  Russian Federation,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical response (cure or failure) in the Clinical Per Protocol population Test of Cure (TOC) visit (Day 12-14) No
Secondary summary of baseline susceptibilities Study endpoint No
Secondary clinical response (cure or failure) in the Clinical Per Protocol population On-Treatment (OT) visit (Day 4-6) No
Secondary Laboratory abnormalities Baseline and TOC visit Yes
Secondary bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population TOC visit No
Secondary adverse events Continuous Yes
Secondary clinical response (cure or failure) in all populations except the Clinical Per Protocol population OT visit and TOC visit No
Secondary clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32) No
Secondary clinical response (cure or failure) in the Clinical Per Protocol population LTFU visit No
Secondary clinical scores for the Clinical Per Protocol population OT visit and TOC visit No
Secondary persistence of middle ear fluid for the Clinical Per Protocol population TOC visit and LTFU visit No
Secondary audiologic response LTFU visit No
See also
  Status Clinical Trial Phase
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Completed NCT04296448 - Evaluation of Cellphone Based Otoscopy in Pediatric Patients N/A
Terminated NCT05651633 - Analgesic Ear Drops for Children With Acute Otitis Media Phase 3
Completed NCT01941381 - Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
Completed NCT02345447 - Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence Phase 3
Recruiting NCT01214538 - Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children N/A
Completed NCT03614117 - Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR) N/A
Recruiting NCT06027593 - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions N/A
Completed NCT02918773 - Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto) N/A
Completed NCT02567747 - Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
Completed NCT02935374 - Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children Phase 4
Completed NCT02567825 - Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media N/A
Completed NCT02037893 - Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media Phase 2
Completed NCT00578773 - A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea Phase 2
Completed NCT00377260 - Acute Otitis Media (AOM) Therapy Trial in Young Children Phase 4
Completed NCT00645112 - A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media Phase 4
Completed NCT00368823 - A Trial of Point of Care Information in Ambulatory Pediatrics Phase 3
Completed NCT01272999 - Impact of Prevnar 13 on Ear Infections in Children

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