Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.

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Detailed Description

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Conditions

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Acute Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.

60 mg/kg azithromycin ER (Extended Release)arm

Group Type ACTIVE_COMPARATOR

60 mg/kg azithromycin ER

Intervention Type DRUG

subjects taken 60 mg/kg azithromycin ER

2.

30 mg/kg azithromycin IR (Immediate Release) arm

Group Type ACTIVE_COMPARATOR

30 mg/kg azithromycin IR

Intervention Type DRUG

subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Interventions

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60 mg/kg azithromycin ER

subjects taken 60 mg/kg azithromycin ER

Intervention Type DRUG

30 mg/kg azithromycin IR

subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Intervention Type DRUG

Other Intervention Names

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Zithromax Zithromax

Eligibility Criteria

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Inclusion Criteria

* Subjects age 6 months to \< 12 years.
* Have clinical signs/symptoms of acute otitis media in at least one ear.
* Parent(s)/legal guardian(s) provide written informed consent.