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Completed

NCT Number: NCT00796224

Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids 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.

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Key information

Conditions

Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, San José, Provincia de San José, Costa Rica

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

60 mg/kg azithromycin ER

Drug

subjects taken 60 mg/kg azithromycin ER

Other names: Zithromax

30 mg/kg azithromycin IR

Drug

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

Other names: Zithromax

Primary outcomes

  1. Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)

    Time frame: Predose/0 to 72 Hours

    AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.

Secondary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)

    Time frame: 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.

  2. Maximum Observed Plasma Concentration (Cmax) of Azithromycin

    Time frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin

    Time frame: 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.

  4. Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)

    Time frame: 1,2,3,4,8,24,48,72 hours postdose

  5. Number of Participants With a Clinical Response

    Time frame: 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

  6. Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 24, 2008
Registry last updated
Feb 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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