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

Condition(s) targeted: Pharmacokinetics

Intervention: azithromycin immediate release (Zithromax) (Drug); placebo (Other); azithromycin SR (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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).

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

Study design: Basic Science, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

Primary outcome:

Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum

Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples

Secondary outcome:

12-lead electrocardiograms (ECGs)

adverse events (AEs)

safety laboratory tests

vital signs

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, Pisa 56126, Italy

To obtain contact information for a study center near you, click here.

Starting date: November 2004
Ending date: April 2005
Last updated: March 19, 2008