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”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: May 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Tigecycline
  • All patients will receive tigecycline infusions approximately every 12 or 24 hours. The usual regimen of tigecycline is (an initial intravenous (IV) dose of 100 mg followed by 50 mg approximately every 12 hours). Patients with severe hepatic dysfunction may, at the investigator's discretion with CPL Associates approval (call enrollment hotline) may be given a total daily dose of 50 mg (one 50 mg dose or 25 mg approximately every 12 hours). Tigecycline infusions will be administered over approximately 30 minutes in 100 mL of normal saline.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1 Tigecycline

Primary Measures

• Time to bacterial eradication
  • Time Frame: 7-14 days
    

Secondary Measures

• Safety and Efficacy of Tigecycline in patients with intravascular catheter infections
  • Time Frame: 7-14 days
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: CPL Associates

Overall Clinical Trial Officials and Contacts

Dennis G Maki, M.D. Principal Investigator University of Wisconsin, Madison  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419991

Study ID Number: CPLA-6625

ClinicalTrials.gov Identifier: NCT00419991

Health Authority: United States: Institutional Review Board

CPL Associates Website