Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Community-Acquired Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Azithromycin microspheres 2.0 single dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No