Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Intrapulmonary Pharmacokinetics of Antibiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315601
Recruitment Status : Terminated (Sanofi-Aventis wanted the study terminated.)
First Posted : April 18, 2006
Last Update Posted : February 13, 2009
Information provided by:
University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Telithromycin Drug: azithromycin Procedure: bronchoalveolar lavage Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects
Study Start Date : January 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Telithromycin
    800 mg once a day for 5 days
    Other Name: Ketek
  • Drug: azithromycin
    500 mg on day 1, and then 250 mg once-daily on days 2 through 5
    Other Name: Zithromax
  • Procedure: bronchoalveolar lavage
    One bronchoscopy with bronchoalveolar lavage with each drug administration
    Other Name: Bronchoscopy with BAL
  • Drug: Telithromycin
    Telithromycin 800 mg once a day
    Other Name: Ketek

Primary Outcome Measures :
  1. Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. How long does the study antibiotics get into the fluids and cells of the lung. [ Time Frame: 7 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315601

Layout table for location information
United States, Arizona
Pulmonary Associates PA
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
University of Illinois at Chicago
Layout table for investigator information
Principal Investigator: Keith A. Rodvold, Pharm.D. University of Illinois at Chicago
Principal Investigator: Mark H. Gotfried, M.D. Pulmonary Associates, PA
Principal Investigator: Larry H. Danziger, Pharm.D. University of Illinois at Chicago

Layout table for additonal information
Responsible Party: University of Illinois at Chicago Identifier: NCT00315601    
Other Study ID Numbers: 2005-0748
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009
Keywords provided by University of Illinois at Chicago:
Telithromycin (drug)
Azithromycin (drug)
Bronchoalveolar lavage (procedure)
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Anti-Infective Agents