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

Staphylococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419991
• Other study ID #: CPLA-6625
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2007
• Last updated: June 21, 2011
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2011
• Source: CPL Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Staphylococcal Infections

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.

Locations

Country	Name	City	State
United States	CPL Associates Investigational Site	Cumberland	Maryland
United States	CPL Associates Investigational Site	Huntsville	Alabama
United States	CPL Associates Investigational Site	Marietta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
CPL Associates	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Schnappinger D, Hillen W. Tetracyclines: antibiotic action, uptake, and resistance mechanisms. Arch Microbiol. 1996 Jun;165(6):359-69. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to bacterial eradication		7-14 days	No
Secondary	Safety and Efficacy of Tigecycline in patients with intravascular catheter infections		7-14 days	Yes

External Links

•   CPL Associates Website