NCT00315601

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

10 months

First QC Date

April 14, 2006

Last Update Submit

February 12, 2009

Conditions

Healthy

Keywords

Telithromycin (drug)Azithromycin (drug)Bronchoalveolar lavage (procedure)Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters

    7 days

Secondary Outcomes (1)

  • How long does the study antibiotics get into the fluids and cells of the lung.

    7 days

Interventions

TelithromycinDRUG

800 mg once a day for 5 days

Also known as: Ketek
azithromycinDRUG

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

Also known as: Zithromax
bronchoalveolar lavagePROCEDURE

One bronchoscopy with bronchoalveolar lavage with each drug administration

Also known as: Bronchoscopy with BAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Associates PA

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Interventions

telithromycinAzithromycinBronchoalveolar LavageBronchoscopy

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsTherapeutic IrrigationInvestigative TechniquesDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

January 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations

US(1)