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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Otitis Media
• Intervention / Treatment: Drug: 60 mg/kg azithromycin ER; Drug: 30 mg/kg azithromycin IR

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Costa Rica
  • San Jose, Costa Rica
    • Pfizer Investigational Site
  • San Jose, Costa Rica, 0000
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1.; 60 mg/kg azithromycin ER (Extended Release)arm	Drug: 60 mg/kg azithromycin ER; subjects taken 60 mg/kg azithromycin ER; Other Names: Zithromax
Active Comparator: 2.; 30 mg/kg azithromycin IR (Immediate Release) arm	Drug: 30 mg/kg azithromycin IR; subjects taken 30 mg/kg azithromycin IR (Immediate Release); Other Names: Zithromax

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: November 18, 2008
• First Submitted That Met QC Criteria: November 20, 2008
• First Posted (Estimate): November 24, 2008

Study Record Updates

• Last Update Posted (Estimate): February 18, 2010
• Last Update Submitted That Met QC Criteria: February 1, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: azithromycin, pharmacokinetics, pediatrics
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: A0661190