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azithromycin sustained release

Phase 3

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

Clinical trial landscape

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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