Skip to main content
OpenTrials
Completed

NCT Number: NCT00644176

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 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacokinetics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site

Pisa, 56126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

azithromycin immediate release (Zithromax)

Drug

azithromycin IR 500 mg tablet by mouth for 1 dose

Placebo

Other

placebo

Azithromycin SR

Drug

2.0 g by mouth in the form of liquid for 1 dose

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 12-lead electrocardiograms (ECGs)

    Time frame: Screening and 72 hours postdose

  2. adverse events (AEs)

    Time frame: Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose

  3. safety laboratory tests

    Time frame: Treatment day 0 and 72 hours postdose

  4. vital signs

    Time frame: Screening and Treatment day 0

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Mar 26, 2008
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.