Open Label Non-Comparative Clinical Trial of Tigecycline in Patients With Catheter Infection
Information source: CPL Associates
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Staphylococcal Infections
Intervention: Tigecycline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: CPL Associates Official(s) and/or principal investigator(s):
Dennis G Maki, M.D., Principal Investigator, Affiliation: University of Wisconsin, Madison
Summary
Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms
and provides activity against emerging multi-drug resistant pathogens. The purpose of this
protocol is to determine the linkage between time related clinical measures of infection
response and time to bacterial eradication in patients with intravascular catheter infections
caused by Staphylococcus epidermidis and other coagulase negative staphylococci.
Clinical Details
Official title: An Open-Label Noncomparative, Multicenter, Clinical Trail Measuring Time Related Clinical Response Factors in Relation to Time to Bacterial Eradication With Tigecycline Treatment in Patients With Catheter Infection
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Time to bacterial eradication
Secondary outcome: Safety and Efficacy of Tigecycline in patients with intravascular catheter infections
Detailed description:
Tigecycline, a glycylcycline antibiotic and an analog of the tetracycline minocycline,
demonstrates a broad spectrum of antibacterial activity by inhibiting multiply resistant
gram-positive, gram-negative, anaerobic, and "atypical" bacteria. It is being developed as
an agent that overcomes tetracycline-resistance mechanisms and provides activity against
emerging multi-drug resistant pathogens. These attributes may provide clinicians with a
valuable therapeutic alternative. The purpose of this protocol is to determine the linkage
between time related clinical measures of infection response and time to bacterial
eradication in patients with intravascular catheter infections caused by Staphylococcus
epidermidis and other coagulase negative staphylococci. The study is being conducted in two
phases. The first treats patients who have removal of the catheter at the time of treatment,
and the second treats patients who have the catheter remaining in situ during tigecycline
treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female patients, 18-85 years of age and a weight of > 45 kilograms.
- Patients with intravascular catheters and a blood culture that is positive for
gram-positive cocci in clusters. Patients will be subsequently excluded from the
study analysis if they do not have a culture-positive infection with S. epidermidis or
other coagulase negative staphylococci, expected to be susceptible to tigecycline.
- Patients in whom the bacteremia can be cultured daily by the site investigator.
- Patients who have failed other available antibiotic therapies may be enrolled with
positive blood cultures and organism susceptibility to tigecycline.
Exclusion Criteria:
- Patients that cannot be cultured daily by the site investigator.
- Intravascular catheter infections known to be caused by bacteria other than a
coagulase negative staphylococci, for example, Staphylococcus aureus.
- Any patient who has received more than 24 hrs of vancomycin.
- Any patient who has received any antibiotic active against S. epidermidis other than
vancomycin.
- Patients who are moribund with an expected survival of less than 2 weeks.
- Patients who are neutropenic (ANC <500) at the time of bacteremia
- Patients who have been designated as "Do Not Resuscitate", unless it is anticipated
within a reasonable degree of medical certainty that they can achieve benefit from
tigecycline therapy.
- Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds
related to this class of antibacterial agents.
- Pregnant women or nursing mothers.
- Female patients of childbearing potential who do not agree to use a medically
acceptable method of contraception throughout the duration of the study and for at
least 1 month after the last dose of tigecycline.
- Patients with suspected or proven endocarditis or osteomyelitis
- Patients with suspected or proven mycobacterial infections
Locations and Contacts
CPL Associates Investigational Site, Huntsville, Alabama 35801, United States
CPL Associates Investigational Site, Marietta, Georgia 30060, United States
CPL Associates Investigational Site, Cumberland, Maryland 21502, United States
Additional Information
CPL Associates Website
Related publications: Schnappinger D, Hillen W. Tetracyclines: antibiotic action, uptake, and resistance mechanisms. Arch Microbiol. 1996 Jun;165(6):359-69. Review. Gales AC, Jones RN. Antimicrobial activity and spectrum of the new glycylcycline, GAR-936 tested against 1,203 recent clinical bacterial isolates. Diagn Microbiol Infect Dis. 2000 Jan;36(1):19-36. Meinl B, Hyatt JM, Forrest A, Chodosh S, Schentag JJ. Pharmacokinetic/pharmacodynamic predictors of time to clinical resolution in patients with acute bacterial exacerbations of chronic bronchitis treated with a fluoroquinolone. Int J Antimicrob Agents. 2000 Nov;16(3):273-80. Ambrose PG, Anon JB, Owen JS, Van Wart S, McPhee ME, Bhavnani SM, Piedmonte M, Jones RN. Use of pharmacodynamic end points in the evaluation of gatifloxacin for the treatment of acute maxillary sinusitis. Clin Infect Dis. 2004 Jun 1;38(11):1513-20. Epub 2004 May 12. Erratum in: Clin Infect Dis. 2005 Jan 15;40(2):341.
Starting date: January 2007
Ending date: May 2008
Last updated: May 5, 2008
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