Intrapulmonary Pharmacokinetics of Antibiotics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The major objectives of this research are to see how much, and for how long, telithromycin and azithromycin get into the fluids and cells of the lung.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Outpatient Registry Trial of Respiratory Tract Infections in Adults

NCT00245453

Pneumonia, Bacterial Bronchitis, Chronic

WITHDRAWN PHASE4

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

NCT00644176

Pharmacokinetics

COMPLETED PHASE2

A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions

NCT00830206

Healthy

COMPLETED PHASE1

KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections

NCT00132951

Respiratory Tract Infections Chronic Bronchitis Pneumonia

TERMINATED PHASE4

An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects

NCT00879983

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations following multiple oral doses of telithromycin and azithromycin in healthy, non-smoking adult subjects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telithromycin

800 mg once a day for 5 days

Intervention Type DRUG

azithromycin

500 mg on day 1, and then 250 mg once-daily on days 2 through 5

Intervention Type DRUG

bronchoalveolar lavage

One bronchoscopy with bronchoalveolar lavage with each drug administration

Intervention Type PROCEDURE

Telithromycin

Telithromycin 800 mg once a day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ketek Zithromax Bronchoscopy with BAL Ketek

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between 18 and 55 years, inclusive, of age
* No history of smoking within the last 1 year
* Body weight within +/- 15% of the Metropolitan Life Insurance Company tables
* No clinically important abnormalities in the medical history or physical exam
* Female subjects of childbearing potential must have a negative pregnancy test
* Female subjects of childbearing potential must use reliable methods of birth control

Exclusion Criteria

* Allergy to telithromycin, azithromycin, or any macrolide antibiotic
* Allergy or serious adverse reactions to benzodiazepines or lidocaine
* History of renal, gastrointestinal, or liver disease
* Significant hypertension
* Clinically significant heart or pulmonary diseases
* History of drug or alcohol dependence within 12 months of study entry
* Positive pregnancy test
* Currently breast feeding
* Use of any drug within 2 weeks of study entry
* Received an investigational drug within 30 days of study entry

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes