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Azithromycin microspheres 2.0 single dose

Phase 3

Community-Acquired Pneumonia | Small molecule | Infectious Disease |Pfizer, Inc.|Trials Updated: May 10, 2011

Azithromycin microspheres 2.0 single dose development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Aug 2005

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Azithromycin microspheres 2.0 single dose clinical trials

Azithromycin microspheres 2.0 single dose · 1 trial · 1 indication

Phase 3 1
NCT00140023Azithromycin Microspheres in Patients With Low Risk Community Acquired PneumoniaCommunity-Acquired Pneumonia
COMPLETED47 Analytics
PHASE3COMPLETED
Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
Community-Acquired PneumoniaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Azithromycin microspheres 2.0 single doseDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 examinat...

Countries:Philippines
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Frequently asked questions about Azithromycin microspheres 2.0 single dose

What is azithromycin microspheres 2.0 single dose?

Azithromycin microspheres 2.0 single dose is an investigational small molecule formulation of azithromycin developed by Pfizer, Inc. (NYSE: PFE) for the treatment of community-acquired pneumonia. It is a single-dose microsphere formulation designed to deliver the antibiotic in one administration. It is currently in Phase 3 clinical development.

What is azithromycin microspheres 2.0 single dose used for?

Azithromycin microspheres 2.0 single dose is being developed for the treatment of community-acquired pneumonia. It is intended for patients with low risk community-acquired pneumonia, as studied in a Phase 3 trial. It is an investigational formulation and is not approved for commercial use.

Who makes azithromycin microspheres 2.0 single dose?

Azithromycin microspheres 2.0 single dose is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical development program for this single-dose microsphere formulation of azithromycin.

What phase is azithromycin microspheres 2.0 single dose in?

Azithromycin microspheres 2.0 single dose is in Phase 3 clinical development. One Phase 3 trial has been completed, and there are currently no active trials. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is azithromycin microspheres 2.0 single dose in?

Azithromycin microspheres 2.0 single dose has been studied in one completed Phase 3 trial, NCT00140023, titled Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia. The trial enrolled 47 patients in the Philippines and was an uncontrolled study in adults aged 18 years and older.