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

Primary Purpose

Staphylococcal Infections

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Tigecycline

About this trial

This is an interventional treatment trial for Staphylococcal Infections focused on measuring Tigecycline, Staphylococcal Infections, Catheter

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CPL Associates Investigational Site
CPL Associates Investigational Site
CPL Associates Investigational Site

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

1 Tigecycline

Arm Description

Outcomes

Primary Outcome Measures

Time to bacterial eradication

Secondary Outcome Measures

Safety and Efficacy of Tigecycline in patients with intravascular catheter infections

Full Information

NCT ID

NCT00419991

First Posted

January 8, 2007

Last Updated

June 21, 2011

Sponsor

CPL Associates

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00419991

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

CPL Associates

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staphylococcal Infections

Keywords

Tigecycline, Staphylococcal Infections, Catheter

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Tigecycline

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Tigecycline

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to bacterial eradication

Time Frame

7-14 days

Secondary Outcome Measure Information:

Title

Safety and Efficacy of Tigecycline in patients with intravascular catheter infections

Time Frame

7-14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis G Maki, M.D.

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

CPL Associates Investigational Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

CPL Associates Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

CPL Associates Investigational Site

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8661929

Citation

Schnappinger D, Hillen W. Tetracyclines: antibiotic action, uptake, and resistance mechanisms. Arch Microbiol. 1996 Jun;165(6):359-69. doi: 10.1007/s002030050339.

Results Reference

background

PubMed Identifier

10744364

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. doi: 10.1016/s0732-8893(99)00092-9.

Results Reference

background

PubMed Identifier

11091047

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. doi: 10.1016/s0924-8579(00)00253-3.

Results Reference

background

PubMed Identifier

15156435

Citation

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. doi: 10.1086/420739. Epub 2004 May 12. Erratum In: Clin Infect Dis. 2005 Jan 15;40(2):341.

Results Reference

background

Links:

URL

http://www.cplassociates.com

Description

CPL Associates Website

Learn more about this trial

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

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