Tigecycline, antibiotic evaluated in surveillance trial

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 20 May 2004 - 0:00 PDT

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International Health Management Associates, Inc. (IHMA) has been commissioned to conduct the Tigecycline Evaluation and Surveillance Trial (T.E.S.T.), a global in vitro surveillance study for tigecycline, a broad-spectrum antibiotic currently under investigation.

The study will evaluate the activity of tigecycline against a variety of bacteria, including strains resistant to currently approved drugs, at approximately 690 hospitals in approximately 35 countries over the next three years. Tigecycline is an injectable glycylcycline, a new class of antibiotics, being developed by Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

"T.E.S.T. is likely one of the largest surveillance studies of its kind ever undertaken. The trial will evaluate the activity of tigecycline against a wide range of clinical pathogens collected from diverse patient populations worldwide.

Almost all bacterial strains have developed some level of antibiotic resistance, so this study will enable us to document with in vitro laboratory data the activity of this new antibiotic against bacterial pathogens, including those exhibiting multiple antibiotic resistance," said Daryl Hoban, Ph.D., Director of Clinical and Laboratory Services.

About T.E.S.T.

T.E.S.T. investigators will collect and evaluate clinically significant isolates from a variety of infection sites. The isolates will be tested in vitro to evaluate the activity of tigecycline compared with currently available antimicrobial agents.

The T.E.S.T. data will build upon the drug's in vitro data collected in ongoing Phase 2 and Phase 3 clinical trials in patients. Phase 2 clinical trials investigated use of tigecycline to treat complicated skin and skin-structure or complicated intra-abdominal infections. Phase 3 clinical trials are nearing completion. Laboratory tests from clinical trials have examined tigecycline's activity against a broad spectrum of pathogens, including gram-positive, gram-negative, anaerobic and multidrug-resistant bacteria.

Need for Broad Spectrum Antibiotics

The U.S. Centers for Disease Control and Prevention (CDC) reports that 70 percent of the bacteria causing hospital-acquired infections are resistant to at least one common antibiotic.(i) These antibiotics include, but are not limited to, penicillins, cephalosporins and vancomycin. Because of increasing rates of resistance among common pathogens, broader-spectrum agents are now required for the empiric therapy of many common bacterial infections.(ii) Delaying the initiation of appropriate antimicrobial therapy has been identified as an important determinant of clinical outcomes in various patient care settings.(iii, iv)

About IHMA

IHMA, a clinical research and marketing consulting organization, specializes in infectious diseases. With its global network of affiliates, IHMA offers the most creative and comprehensive menu of products and services to companies developing and marketing antimicrobial agents.

(i) CDC, "Antimicrobial Resistance: A Growing Threat to Public Health," June 1999, Updated Nov. 9, 2002, available at: http://www.cdc.gov/ncidod/hip/Aresist/am_res.htm.

(ii) Cosgrove CE, Carmeli Y. The Impact of Antimicrobial Resistance on Health and Economic Outcomes. Clin Infect Dis 2003;36:1433-1437.

(iii) Lodise TP, McKinnon PS, Swiderski L, Rybak MJ. Outcomes Analysis of Delayed Antibiotic Treatment for Hospital-Acquired Antibiotic Treatment for Hospital-Acquired Staphylococcus aureus Bacteremia. Clin Infect Dis 2003;36:1418-1423.

(iv) Kollef MH, Ward S Sherman G, et al. Inadequate treatment of nosocomial infections is associated with certain emopiric antibiotic choices. Crit Care Med 2000;28:3456-3464.

Contact: Jennifer Petra
jpetra@porternovelli.com
212-601-8110
Porter Novelli

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