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Trial record 1 of 1 for:    NCT00644176
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00644176
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 26, 2008
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • 12-lead electrocardiograms (ECGs) [ Time Frame: Screening and 72 hours postdose ]
  • adverse events (AEs) [ Time Frame: Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose ]
  • safety laboratory tests [ Time Frame: Treatment day 0 and 72 hours postdose ]
  • vital signs [ Time Frame: Screening and Treatment day 0 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: azithromycin immediate release (Zithromax)
    azithromycin IR 500 mg tablet by mouth for 1 dose
  • Other: placebo
    placebo
  • Drug: azithromycin SR
    2.0 g by mouth in the form of liquid for 1 dose
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: azithromycin immediate release (Zithromax)
    • Other: placebo
  • Experimental: 2
    Interventions:
    • Drug: azithromycin SR
    • Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2011)
66
Original Actual Enrollment  ICMJE
 (submitted: March 19, 2008)
64
Actual Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644176
Other Study ID Numbers  ICMJE A0661145
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2011

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