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 - Tabular View

Tracking Information

First Received Date ^ICMJE

March 19, 2008

Last Updated Date

March 19, 2008

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Pharmacokinetics

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00644176

Responsible Party

Director, Clinical Trial Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A0661145

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP