Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pharmacokinetics | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| azithromycin immediate release (Zithromax) | Drug | — | UNRESOLVED |
| azithromycin SR | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: azithromycin immediate release (Zithromax)
- Other: placebo
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: azithromycin SR
- Other: placebo
Primary outcomes (2)
- measure
- Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
- timeFrame
- predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
- measure
- Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available