NCT00796224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 25, 2010

Completed
Last Updated

February 18, 2010

Status Verified

February 1, 2010

Enrollment Period

2 months

First QC Date

November 18, 2008

Results QC Date

December 15, 2009

Last Update Submit

February 1, 2010

Conditions

Acute Otitis Media

Keywords

azithromycin, pharmacokinetics, pediatrics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

1.

ACTIVE COMPARATOR

60 mg/kg azithromycin ER (Extended Release)arm

Drug: 60 mg/kg azithromycin ER

2.

ACTIVE COMPARATOR

30 mg/kg azithromycin IR (Immediate Release) arm

Drug: 30 mg/kg azithromycin IR

Interventions

60 mg/kg azithromycin ERDRUG

subjects taken 60 mg/kg azithromycin ER

Also known as: Zithromax
1.
30 mg/kg azithromycin IRDRUG

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

Also known as: Zithromax
2.

Eligibility Criteria

Age6 Months - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Clinical significant other disease.
  • Recent use of investigational drugs, prescription or nonprescription drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

San José, Provincia de San José, 0000, Costa Rica

Location

Pfizer Investigational Site

San José, Provincia de San José, Costa Rica

Location

Related Links

MeSH Terms

Conditions

Otitis Media

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 18, 2008

First Posted

November 24, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 18, 2010

Results First Posted

January 25, 2010

Record last verified: 2010-02

Locations

CO(2)