Open Label Non-Comparative Clinical Trial of Tigecycline in Patients With Catheter Infection - Full Text View

Sponsor:	CPL Associates
Collaborator:	Wyeth
Information provided by:	CPL Associates
ClinicalTrials.gov Identifier:	NCT00419991

Purpose

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.

Condition	Intervention	Phase
Staphylococcal Infections	Drug: Tigecycline	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Staphylococcal Infections

Drug Information available for: Tigecycline

U.S. FDA Resources

Further study details as provided by CPL Associates:

Primary Outcome Measures:

Time to bacterial eradication [ Time Frame: 7-14 days ]

Secondary Outcome Measures:

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

Enrollment:	10
Study Start Date:	January 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Tigecycline: No Intervention	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

Assigned Interventions

1 Tigecycline: No Intervention

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.

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

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419991

Locations

United States, Alabama
CPL Associates Investigational Site
Huntsville, Alabama, United States, 35801
United States, Georgia
CPL Associates Investigational Site
Marietta, Georgia, United States, 30060
United States, Maryland
CPL Associates Investigational Site
Cumberland, Maryland, United States, 21502

Sponsors and Collaborators

CPL Associates

Wyeth

Investigators

Principal Investigator:

Dennis G Maki, M.D.

University of Wisconsin, Madison

More Information

Additional Information:

CPL Associates Website This link exits the ClinicalTrials.gov site

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.

Responsible Party:	CPL Associates, LLC ( Jerome Schentag, Pharm.D. )
Study ID Numbers:	CPLA-6625
Study First Received:	January 8, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00419991 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by CPL Associates:

Tigecycline
Staphylococcal Infections
Catheter

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Staphylococcal Infections
Communicable Diseases

Gram-Positive Bacterial Infections
Tigecycline
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010