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Doripenem Phase 3 Clinical Trial Initiated, Treatment for Hospital-Acquired Pneumonia
This phase III trial will compare the safety and efficacy of doripenem for injection with that of intravenous piperacillin/tazobactam in the treatment of hospital-acquired pneumonia. In accordance with FDA guidelines, the primary endpoint of the trial is clinical response at the test of cure visit (seven to fourteen days following completion of therapy) in those patients who have been enrolled in the study with a confirmed bacterial pathogen. Patients will be enrolled in various countries around the world.
According to the U.S. Centers for Disease Control, hospital-acquired pneumonia (HAP) is the second most common nosocomial infection in the United States, accounting for approximately 15% of all hospital-associated infections, and is associated with significant morbidity and mortality and increased hospitalization costs. For patients with HAP, attributable mortality rates of 20 to 33% have been reported. HAP can also prolong ICU stays by an average of 4 to 6 days and hospitalization by 4 to 9 days, resulting in increased utilization of medical resources and healthcare costs. The pathogens most frequently associated with HAP are gram-negative bacteria such as Pseudomonas aeruginosa, and Staphylococcus aureus.
"We are pleased to be moving doripenem forward in another important indication," said Matthew A. Wikler, M.D., FIDSA, Chief Medical Officer and Executive Vice President at Peninsula. "We believe that doripenem will prove to be a valuable antibiotic for the treatment of life-threatening infections in hospitalized patients. We are encouraged by the data that has been generated to date with doripenem and are committed to advancing it further for numerous indications."
Doripenem has demonstrated in vitro activity against many aerobic and anaerobic Gram-positive and Gram-negative bacteria, including Enterobacteriaceae strains (including Escherichia coli and other extended spectrum beta-lactamase-producing strains) and Pseudomonas aeruginosa.
Peninsula is also developing an inhaled version of doripenem to manage pulmonary infections in Cystic Fibrosis patients. Peninsula licensed North American, South American, and European rights for doripenem from Shionogi & Co. Ltd.
Source: Peninsula Pharmaceuticals, Inc.