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. |
ClinicalTrials.gov Identifier: NCT00315601 |
Recruitment Status
:
Terminated
(Sanofi-Aventis wanted the study terminated.)
First Posted
: April 18, 2006
Last Update Posted
: February 13, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Telithromycin Drug: azithromycin Procedure: bronchoalveolar lavage | Phase 4 |
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 |

-
Drug: Telithromycin
- Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters [ Time Frame: 7 days ]
- How long does the study antibiotics get into the fluids and cells of the lung. [ Time Frame: 7 days ]

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.
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

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
United States, Arizona | |
Pulmonary Associates PA | |
Phoenix, Arizona, United States, 85006 |
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 |
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 |