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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643292
First received: March 19, 2008
Last updated: May 16, 2011
Last verified: May 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • summary of baseline susceptibilities [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]
  • clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: On-Treatment (OT) visit (Day 4-6) ] [ Designated as safety issue: No ]
  • Laboratory abnormalities [ Time Frame: Baseline and TOC visit ] [ Designated as safety issue: Yes ]
  • bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • clinical response (cure or failure) in all populations except the Clinical Per Protocol population [ Time Frame: OT visit and TOC visit ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: LTFU visit ] [ Designated as safety issue: No ]
  • clinical scores for the Clinical Per Protocol population [ Time Frame: OT visit and TOC visit ] [ Designated as safety issue: No ]
  • persistence of middle ear fluid for the Clinical Per Protocol population [ Time Frame: TOC visit and LTFU visit ] [ Designated as safety issue: No ]
  • audiologic response [ Time Frame: LTFU visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Months to 48 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643292

  Show 49 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643292     History of Changes
Other Study ID Numbers: A0661073
Study First Received: March 19, 2008
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014