Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection

Completed · Phase 4

Conditions studied: Staphylococcal Infections

In brief

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.

Key facts

Study ID

NCT00419991

Run by

CPL Associates

People needed

10

Starts

2007-01-01

Expected to finish

2008-05-01

Last updated by the study team

2011-06-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• CPL Associates Investigational Site — Huntsville, Alabama, United States
• CPL Associates Investigational Site — Marietta, Georgia, United States
• CPL Associates Investigational Site — Cumberland, Maryland, United States

Full record on ClinicalTrials.gov

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