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

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.

Timeline

Start

2007-01

Primary completion

2008-05

Completion

2008-05

Publications

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

Drugs

Indications