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OpenTrials
Completed

NCT Number: NCT00140023

Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

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.

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Key information

Conditions

Community-Acquired Pneumonia Community-Acquired Infections Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Manila, National Capital Region, Philippines

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Azithromycin microspheres 2.0 single dose

Drug

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multi-center, Open Label Study to Evaluate the Efficacy and Safety of Azithromycin Microspheres in Subjects Identified as Having Low Risk Community Acquired Pneumonia (CAP)

Important dates

Study start
2005
Study completion
2006
First posted
Aug 31, 2005
Registry last updated
May 10, 2011

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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