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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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00644176
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
5
Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: azithromycin immediate release (Zithromax)
  • Other: placebo
  • Drug: azithromycin SR
  • Other: placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Nov 1, 2004
Actual Study Completion Date :
Apr 1, 2005

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

Secondary Outcome Measures

  1. 12-lead electrocardiograms (ECGs) [Screening and 72 hours postdose]

  2. adverse events (AEs) [Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose]

  3. safety laboratory tests [Treatment day 0 and 72 hours postdose]

  4. vital signs [Screening and Treatment day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Pisa Italy 56126

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00644176
Other Study ID Numbers:
  • A0661145
First Posted:
Mar 26, 2008
Last Update Posted:
Jun 8, 2011
Last Verified:
Jun 1, 2011
Additional relevant MeSH terms:
Azithromycin

Study Results

No Results Posted as of Jun 8, 2011