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Intrapulmonary Pharmacokinetics of Antibiotics

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ClinicalTrials.gov Identifier: NCT00315601
Recruitment Status : Terminated (Sanofi-Aventis wanted the study terminated.)
First Posted : April 18, 2006
Last Update Posted : February 13, 2009
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Illinois at Chicago

Study Description
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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.

Study Design
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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

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Arms and Interventions
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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

Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00315601


Locations
United States, Arizona
Pulmonary Associates PA
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
University of Illinois at Chicago
Sanofi
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00315601     History of Changes
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)
Pharmacokinetics

Additional relevant MeSH terms:
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents