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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: azithromycin immediate release (Zithromax)
* Other: placebo
* Drug: azithromycin SR
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: azithromycin immediate release (Zithromax)<br>* azithromycin IR 500 mg tablet by mouth for 1 dose<br>Other: placebo<br>* placebo<br>|
| Experimental: 2<br> | Drug: azithromycin SR<br>* 2.0 g by mouth in the form of liquid for 1 dose<br>Other: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |