NCT00419991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

1.3 years

First QC Date

January 8, 2007

Last Update Submit

June 21, 2011

Conditions

Staphylococcal Infections

Keywords

TigecyclineStaphylococcal InfectionsCatheter

Outcome Measures

Primary Outcomes (1)

  • Time to bacterial eradication

    7-14 days

Secondary Outcomes (1)

  • Safety and Efficacy of Tigecycline in patients with intravascular catheter infections

    7-14 days

Study Arms (1)

1 Tigecycline

NO INTERVENTION
Drug: Tigecycline

Interventions

TigecyclineDRUG

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.

1 Tigecycline

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CPL Associates Investigational Site

Huntsville, Alabama, 35801, United States

Location

CPL Associates Investigational Site

Marietta, Georgia, 30060, United States

Location

CPL Associates Investigational Site

Cumberland, Maryland, 21502, United States

Location

Related Publications (4)

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

    PMID: 8661929BACKGROUND

  • 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.

    PMID: 10744364BACKGROUND

  • 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.

    PMID: 11091047BACKGROUND

  • 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.

    PMID: 15156435BACKGROUND

Related Links

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Dennis G Maki, M.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

US(3)