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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644176
First received: March 19, 2008
Last updated: June 3, 2011
Last verified: June 2011
  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 2

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


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: 66
Study Start Date: November 2004
Study Completion Date: April 2005
Arms Assigned Interventions
Experimental: 1 Drug: azithromycin immediate release (Zithromax)
azithromycin IR 500 mg tablet by mouth for 1 dose
Other: placebo
placebo
Experimental: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Director, Clinical Trial Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644176     History of Changes
Other Study ID Numbers: A0661145
Study First Received: March 19, 2008
Last Updated: June 3, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014