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Trial record 1 of 1 for:    NCT00643292
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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

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ClinicalTrials.gov Identifier: NCT00643292
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 26, 2008
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)		 clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 12-14) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • summary of baseline susceptibilities [ Time Frame: Study endpoint ]
  • clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: On-Treatment (OT) visit (Day 4-6) ]
  • Laboratory abnormalities [ Time Frame: Baseline and TOC visit ]
  • bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ]
  • adverse events [ Time Frame: Continuous ]
  • clinical response (cure or failure) in all populations except the Clinical Per Protocol population [ Time Frame: OT visit and TOC visit ]
  • clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population [ Time Frame: OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32) ]
  • clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: LTFU visit ]
  • clinical scores for the Clinical Per Protocol population [ Time Frame: OT visit and TOC visit ]
  • persistence of middle ear fluid for the Clinical Per Protocol population [ Time Frame: TOC visit and LTFU visit ]
  • audiologic response [ Time Frame: LTFU visit ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Otitis Media
Intervention  ICMJE
  • Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
    amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
  • Drug: azithromycin SR
    azithromycin SR 60 mg/kg x 1 dose
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
  • Experimental: 2
    Intervention: Drug: azithromycin SR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2008)		 902
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 48 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Costa Rica,   Dominican Republic,   Estonia,   Guatemala,   Israel,   Mexico,   Panama,   Poland,   Russian Federation,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643292
Other Study ID Numbers  ICMJE A0661073
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP