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

Study Overview
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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.

Official Title
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A Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release Or Extended-Release Formulation In Pediatric Subjects With Acute Otitis Media

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Drug: 60 mg/kg azithromycin ER
* Drug: 30 mg/kg azithromycin IR


Participation Criteria
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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. Exclusion Criteria: Clinical significant other disease. Recent use of investigational drugs, prescription or nonprescription drugs.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.<br>60 mg/kg azithromycin ER (Extended Release)arm | Drug: 60 mg/kg azithromycin ER<br>* subjects taken 60 mg/kg azithromycin ER<br>* Other names: Zithromax;|
| Active Comparator: 2.<br>30 mg/kg azithromycin IR (Immediate Release) arm | Drug: 30 mg/kg azithromycin IR<br>* subjects taken 30 mg/kg azithromycin IR (Immediate Release)<br>* Other names: Zithromax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) | AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours. | Predose/0 to 72 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) | AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) of Azithromycin |  | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half. | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | 
| Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) |  | 1,2,3,4,8,24,48,72 hours postdose | 
| Number of Participants With a Clinical Response | Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following: Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary; New clinical signs and symptoms of acute illness have developed and additional therapy is necessary | Days 7,8,9 or 10 | 
| Adverse Events (AEs) and Serious AEs (SAEs) | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported. | Baseline up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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azithromycin, pharmacokinetics, pediatrics