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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644176
• Other study ID #: A0661145
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2008
• Last updated: June 3, 2011
• Start date: November 2004
• Est. completion date: April 2005

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Other:
• placebo
placebo

Locations

Country	Name	City	State
Italy	Pfizer Investigational Site	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	12-lead electrocardiograms (ECGs)		Screening and 72 hours postdose	Yes
Secondary	adverse events (AEs)		Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose	Yes
Secondary	safety laboratory tests		Treatment day 0 and 72 hours postdose	Yes
Secondary	vital signs		Screening and Treatment day 0	Yes

External Links

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