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

Phase 2

Completed

• Conditions: Acute Otitis Media
• Interventions: Drug: 60 mg/kg azithromycin ER; Drug: 30 mg/kg azithromycin IR

• Registration Number: NCT00796224
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-24
• Study Start: 2008-12
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2009-12-15
• Results First Submitted QC: 2009-12-16
• Results First Posted: 2010-01-25
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.	60 mg/kg azithromycin ER	60 mg/kg azithromycin ER (Extended Release)arm
2.	30 mg/kg azithromycin IR	30 mg/kg azithromycin IR (Immediate Release) arm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)	Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose	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.
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	Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.
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	Days 7,8,9 or 10	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
Adverse Events (AEs) and Serious AEs (SAEs)	Baseline up to 28 days	All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇷 San Jose, Costa Rica