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

NCT00419991

Last updated date
Study Location
CPL Associates Investigational Site
Huntsville, Alabama, 35801, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Staphylococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Staphylococcal Infections
Intervention  ICMJE 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.
Study Arms  ICMJE No Intervention: 1 Tigecycline
Intervention: Drug: Tigecycline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2008)
10
Original Enrollment  ICMJE
 (submitted: January 8, 2007)
40
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00419991
Other Study ID Numbers  ICMJE CPLA-6625
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jerome Schentag, Pharm.D., CPL Associates, LLC
Study Sponsor  ICMJE CPL Associates
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Dennis G Maki, M.D.University of Wisconsin, Madison
PRS Account CPL Associates
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP