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NCT00644176 Clinical Trial

A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Surgery

Pharmacokinetics Clinical Trial

Official title:
A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin in Serum, Bronchial Washings and Lung Tissue Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Resection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00644176
Other study ID # A0661145
Secondary ID
Status Completed
Phase Phase 2
First received March 19, 2008
Last updated June 3, 2011
Start date November 2004
Est. completion date April 2005

Study information
Verified date June 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this trial was to characterize the pharmacokinetics of the currently marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin sustained release liquid formulation (AZ-SR) in lung tissue and bronchial washings, the latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly alveolar macrophages (AM).

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Inclusion criteria were hospitalized subjects diagnosed with lung cancer that had consented to surgery requiring lung resection who had a life expectancy of >6 months.

Exclusion Criteria:

Key exclusion criteria were antibiotic prophylaxis prior to surgery, diffuse, non-infectious lung disease, history of cigarette smoking of >5 packs per year, patients with any infectious disease that required antibiotic therapy, administration of drugs known to interfere with azithromycin pharmacokinetics, and subjects on chemotherapy.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• azithromycin immediate release (Zithromax)
azithromycin IR 500 mg tablet by mouth for 1 dose
Other:
• placebo
placebo
Drug:
• azithromycin SR
2.0 g by mouth in the form of liquid for 1 dose
Other:
• placebo
placebo

Locations
Country Name City State
Italy Pfizer Investigational Site Pisa

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose No
Primary Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose No
Secondary 12-lead electrocardiograms (ECGs) Screening and 72 hours postdose Yes
Secondary adverse events (AEs) Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose Yes
Secondary safety laboratory tests Treatment day 0 and 72 hours postdose Yes
Secondary vital signs Screening and Treatment day 0 Yes
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