Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140023

Enrollment

Registered

2005-08-31

Start date

2005-09-30

Completion date

2006-06-30

Last updated

2011-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-Acquired Pneumonia

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.

Interventions

DRUGAzithromycin microspheres 2.0 single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.	—

Secondary

Measure	Time frame
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.	—

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026