HealthyPhase 4NCT00315601
Intrapulmonary Pharmacokinetics of Antibiotics
A Phase 4 study testing Telithromycin, azithromycin and bronchoalveolar lavage in people with Healthy, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telithromycin, azithromycin and bronchoalveolar lavage
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Telithromycin, azithromycin, bronchoalveolar lavage
- Keywords
- Telithromycin (drug), Azithromycin (drug), Bronchoalveolar lavage (procedure), Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelithromycinDrug
Also called Ketek
800 mg once a day for 5 days
azithromycinDrug
Also called Zithromax
500 mg on day 1, and then 250 mg once-daily on days 2 through 5
bronchoalveolar lavageProcedure or surgery
Also called Bronchoscopy with BAL
One bronchoscopy with bronchoalveolar lavage with each drug administration
TelithromycinDrug
Also called Ketek
Telithromycin 800 mg once a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters
Measured: 7 days
Secondary outcomes (1)
How long does the study antibiotics get into the fluids and cells of the lung.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startJan 2006
- Primary completionNov 2006
- Study completionNov 2006
Why it stopped: Sanofi-Aventis wanted the study terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Keith A. Rodvold, Pharm.D., Principal investigator, University of Illinois ChicagoMark H. Gotfried, M.D., Principal investigator, Pulmonary Associates, PALarry H. Danziger, Pharm.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315601
- Sponsor's protocol ID
- 2005-0748
- Status last verified
- Feb 2009
- First submitted
- 14 Apr 2006
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00315601
- Acronym / sponsor ID
- 2005-0748
- Conditions
- Healthy
- Keywords
- Telithromycin (drug), Azithromycin (drug), Bronchoalveolar lavage (procedure), Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sanofi-Aventis wanted the study terminated.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelithromycinAlso: Ketek800 mg once a day for 5 days | Drug | – |
| azithromycinAlso: Zithromax500 mg on day 1, and then 250 mg once-daily on days 2 through 5 | Drug | – |
| bronchoalveolar lavageAlso: Bronchoscopy with BALOne bronchoscopy with bronchoalveolar lavage with each drug administration | Procedure or surgery | – |
| TelithromycinAlso: KetekTelithromycin 800 mg once a day | Drug | – |
Primary outcome
Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters
Time frame: 7 days
1 secondary outcome
How long does the study antibiotics get into the fluids and cells of the lung.
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Sanofi-Aventis wanted the study terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith A. Rodvold, Pharm.D. principal investigator
University of Illinois Chicago
Mark H. Gotfried, M.D. principal investigator
Pulmonary Associates, PA
Larry H. Danziger, Pharm.D. principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telithromycin, azithromycin and bronchoalveolar lavage in people with Healthy, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sanofi-Aventis wanted the study terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2009.