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

Phase 2

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: azithromycin immediate release (Zithromax); Drug: azithromycin SR; Other: placebo

• Registration Number: NCT00644176
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2004-11
• Study Completion: 2005-04
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-26
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-03
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
1	azithromycin immediate release (Zithromax)	-
2	azithromycin SR	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
12-lead electrocardiograms (ECGs)	Screening and 72 hours postdose
adverse events (AEs)	Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
safety laboratory tests	Treatment day 0 and 72 hours postdose
vital signs	Screening and Treatment day 0

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇹 Pisa, Italy