NCT00140023

Brief Summary

The study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after starting the study drug; those subjects from whom a baseline pathogen is identified will also be assessed for bacteriologic response. All subjects who receive 1 dose of study medication will be assessed for safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

5 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

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

First QC Date

August 29, 2005

Last Update Submit

May 9, 2011

Conditions

Community-Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.

Secondary Outcomes (1)

  • To assess bacteriological efficacy of 2.0 g single dose of azithromycin microspheres. To assess the safety and tolerability of 2.0 g single dose of azithromycin microspheres.

Interventions

Azithromycin microspheres 2.0 single doseDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 years age or older, for whom oral, outpatient therapy is indicated.
  • Diagnosis of CAP as manifested by at least 3 or more of the following:
  • cough, pleuritic chest pain, fever (temperature of \>37.8 C to \<40 C), auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation, dyspnea, tachypnea, laboratory results of elevated total peripheral white blood count (WBC\> 10,000/mm3 or greater than 15% immature neutrophils (bands)

You may not qualify if:

  • Known or suspected hypersensitivity or intolerance to azithromycin or other macrolides.
  • Previously diagnosed disease(s) of immune function, including: subjects with baseline absolute neutrophil count \< 1,000/mm3, HIV positive subjects with CD4 count \< 200 cells/mm3, any immunoglobin or neutrophil disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Manila, National Capital Region, 1000, Philippines

Location

Pfizer Investigational Site

City of Muntinlupa, Philippines

Location

Pfizer Investigational Site

Mandaluyong, Philippines

Location

Pfizer Investigational Site

Manila, Philippines

Location

Pfizer Investigational Site

Quezon City, Philippines

Location

Related Links

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

September 1, 2005

Study Completion

June 1, 2006

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations

PH(5)