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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644176

Purpose

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).

Condition	Intervention	Phase
Pharmacokinetics	Drug: azithromycin immediate release (Zithromax) Other: placebo Drug: azithromycin SR	Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum [ Time Frame: predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples [ Time Frame: 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

12-lead electrocardiograms (ECGs) [ Time Frame: Screening and 72 hours postdose ] [ Designated as safety issue: Yes ]
adverse events (AEs) [ Time Frame: Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose ] [ Designated as safety issue: Yes ]
safety laboratory tests [ Time Frame: Treatment day 0 and 72 hours postdose ] [ Designated as safety issue: Yes ]
vital signs [ Time Frame: Screening and Treatment day 0 ] [ Designated as safety issue: Yes ]

Enrollment:	64
Study Start Date:	November 2004
Study Completion Date:	April 2005

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644176

Locations

Italy
Pfizer Investigational Site
Pisa, Italy, 56126

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Group )
Study ID Numbers:	A0661145
Study First Received:	March 19, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00644176 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Azithromycin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009