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Title: Tigecycline Effective for Complicated Infections in Hospitalized Patients: Presented at ICAAC

"Tigecycline Effective for Complicated Infections in Hospitalized Patients: Presented at ICAAC"

W. A. Thomasson, PhD CHICAGO, IL -- September 22, 2003 -- Tigecycline may effectively treat complicated intra-abdominal infections, as well as complicated skin and skin structure infections in hospitalized patients, according to two phase II studies presented here September 15th at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy. Human intestinal flora encompass more than 400 different species, noted James Murray, MD, Los Angeles County + University of Southern California (LAC+USC) Medical Center, who presented the studies. Dr. Murray and colleagues at other Southern California institutions as well as at Wyeth enrolled 72 patients with complicated appendicitis, 19 with perforations and/or peritonitis, and 20 with other complicated intra-abdominal infections. All patients were treated with tigecycline and some received surgical treatment or drainage. Sixty-six patients were considered evaluable for efficacy. Of these, 75.8% were considered clinically cured at the end of treatment, although of these, 12% were later recorded as failures on the test-of-cure visit at least 28 days after the start of treatment. Most adverse events appeared related to the infection or to other procedures employed, although one patient experienced Clostridium difficile colitis of moderate severity that the investigator considered possibly related to tigecycline. There were no withdrawals due to adverse events. In a second study, Russell Postier, MD, University of Oklahoma Medical Center, Oklahoma City, and colleagues from Wyeth and other U.S. institutions used tigecycline to treat complicated skin and skin-structure infections in hospitalized patients. These were infected skin ulcers, major abscesses, infected burns, infected bites, and infections or abscesses with a high likelihood of Gram-negative or anaerobic pathogens. A total of 160 patients were enrolled, with 79 assigned to receive 25 mg tigecycline twice daily and 81 to receive 50 mg twice daily. In the first and second groups, respectively, 26 patients and 31 patients received other antibiotics as well. At the end of the treatment period, there were 55 evaluable patients in the 25-mg group and 54 in the 50-mg group. The cure rate was 78.2% with the 25-mg dose and 85.2% with the 50-mg dose. In each group, 10.9% and 11.1% of patients, respectively, were reclassified as failures at the test-of-cure visit. Evelyn Ellis Gracey, PhD, Clinical Project Team Leader, Wyeth, Madison, New Jersey, noted that tigecycline, the first member of the glycylcycline class, was developed because of its broad spectrum (covering Gram-positive, Gram-negative, anaerobic, and atypical bacteria) as well as because of the need for new agents to counter emerging resistance to currently available drugs. The authors of both studies concluded that larger, double-blind trials are in order. [Study title: "The Clinical Response to Tigecycline in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Patients, a Phase 2 Clinical Trial". Abstract 739; Study title: "Results of a Phase 2, Open-Label, Safety, and Efficacy Study of Tigecycline to Treat Complicated Skin and Skin Structure Infections in Hospitalized Patients". Abstract L-738]

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