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azithromycin sustained release

Phase 3

Pneumonia | Small molecule | Infectious Disease |Pfizer, Inc.|Trials Updated: Mar 26, 2008

azithromycin sustained release development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment468

FDA Designations

No designations recorded

azithromycin sustained release clinical trials

azithromycin sustained release · 1 trial · 1 indication

Phase 3 1
NCT00643734A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult PatientsPneumonia
COMPLETED468 Analytics
PHASE3COMPLETED
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients
PneumoniaUnlock trial analytics

Study Endpoints

Primary Endpoints

sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Test of Cure (TOC) visit (Days 14-21)

Secondary Endpoints

laboratory abnormalities
Baseline and TOC visit
sponsor assessment of clinical response (cure or failure) in the remaining study populations
EOT visit and TOC visit
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
EOT visit and TOC visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
azithromycin sustained releaseDRUGazithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
placeboOTHERplacebo
levofloxacinDRUG500 mg (two 250 mg capsules) by mouth once daily for 7 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included. Exclusion Criteria: Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose o...

Countries:United StatesCanadaChileIndiaLithuaniaMexicoPeruRussia
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Competitive Landscape -Pneumonia 20 trials

Top 4 of 7 competitors

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Frequently asked questions about azithromycin sustained release

What is azithromycin sustained release?

Azithromycin sustained release is an investigational formulation of the antibiotic azithromycin developed by Pfizer, Inc. (ticker: PFE). It is a small molecule being studied for the treatment of pneumonia. The sustained-release design is intended to deliver the drug over an extended period, though the specific pharmacokinetic properties are not detailed here.

What is azithromycin sustained release used for?

Azithromycin sustained release is being developed for the treatment of pneumonia. It is intended for adults with mild to moderate pneumonia, as studied in a Phase 3 clinical trial. The drug has not been approved for any indication and remains investigational.

Who makes azithromycin sustained release?

Azithromycin sustained release is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical trial evaluating this formulation.

What phase is azithromycin sustained release in?

Azithromycin sustained release is in Phase 3 clinical development. A single Phase 3 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is azithromycin sustained release in?

Azithromycin sustained release has been evaluated in one completed Phase 3 trial, NCT00643734. This multicenter, randomized, double-blind, double-dummy study compared azithromycin sustained release with levofloxacin for the treatment of mild to moderate pneumonia in adults. The trial enrolled 468 patients across the United States, Canada, Chile, India, Lithuania, Mexico, Peru, and Russia.