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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00643292
First Posted: March 26, 2008
Last Update Posted: May 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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

Condition Intervention Phase
Acute Otitis Media Drug: amoxicillin/clavulanate postassium (Augmentin ES-600) Drug: azithromycin SR Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 12-14) ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 902
Study Start Date: January 2003
Study Completion Date: May 2004
Arms Assigned Interventions
Experimental: 1 Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
Experimental: 2 Drug: azithromycin SR
azithromycin SR 60 mg/kg x 1 dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643292


  Show 47 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643292     History of Changes
Other Study ID Numbers: A0661073
First Submitted: March 19, 2008
First Posted: March 26, 2008
Last Update Posted: May 17, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action