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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00643292

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Ear Infections

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Clavulanate potassium Amoxicillin trihydrate Amoxicillin-potassium clavulanate combination Azithromycin

U.S. FDA Resources

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
Estimated Study Completion Date:	May 2004

Arms	Assigned Interventions
1: Experimental	Drug: amoxicillin/clavulanate postassium (Augmentin ES-600) amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
2: Experimental	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

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

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Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Anti-Infective Agents
Amoxicillin
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Otitis Media
Clavulanic Acids
Enzyme Inhibitors
Amoxicillin-Potassium Clavulanate Combination

Ear Diseases
Pharmacologic Actions
Anti-Bacterial Agents
Otitis
Azithromycin
Clavulanic Acid
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010