Status:
COMPLETED
Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection
Lead Sponsor:
CPL Associates
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Staphylococcal Infections
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 d...
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-nega...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00419991
Start Date
January 1 2007
End Date
May 1 2008
Last Update
June 22 2011
Active Locations (3)
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1
CPL Associates Investigational Site
Huntsville, Alabama, United States, 35801
2
CPL Associates Investigational Site
Marietta, Georgia, United States, 30060
3
CPL Associates Investigational Site
Cumberland, Maryland, United States, 21502