To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Investigational Antibiotic May be a Weapon in War Against Resistant Bacteria URL: http://www.pslgroup.com/dg/2D70A.htm Doctor's Guide June 30, 1997
SYDNEY, Australia, June 30, 1997 -- The investigational antibiotic Synercid(R) (quinupristin/dalfopristin) appears to be a promising new treatment for serious to potentially life-threatening infections caused by bacteria that resist many available therapies, according to research presented during a scientific symposium at the 20th International Congress of Chemotherapy. New clinical data on the first injectable streptogramin antibiotic has been made available as infectious disease specialists struggle against the escalating, global threat of Gram-positive antibiotic resistance. Vancomycin-Resistant Enterococcus faecium (VREF) The rise of vancomycin-resistant Enterococcus faecium (VREF) infections has proven increasingly challenging to physicians in selecting appropriate antibiotics. Robert C. Moellering, M.D., Shields Warren-Mallinckrodt professor of medical research at Harvard Medical School, Boston, Massachusetts, USA, reported on the safety and efficacy of Synercid in severely ill patients -- such as those who have undergone organ transplantation, hematologic disorders, mechanical ventilation or dialysis. Enrollment criteria for these patients included positive cultures for pathogens resistant to all clinically appropriate antibiotics but thought to be susceptible to Synercid, and signs and symptoms of infection. Dr. Moellering reported a clinical response rate (cure and improvement) of 73.8 percent in 195 clinically evaluable patients, and a bacteriologic response rate (pathogens eradicated and presumed eradicated) of 70.9 percent. Joint pain was the most common adverse effect, noted in 11.3 percent of the patients. Nosocomial Pneumonia Reporting the results of a comparative study conducted in 74 investigational sites in five different countries (France, Germany, Spain, Sweden and US), Jean-Yves Fagon, M.D., director, Division of Critical Care Medicine, Hopital Broussais-Universite Paris IV, found an overall clinical response rate of 56.3 percent with the Synercid-treated patients versus 58.3 percent in those who received vancomycin. In patients who were intubated at entry into the study, the response rates were 54.2 percent and 53.7percent, respectively, and among patients with Staphylococcus aureus infections, the eradication rates were 57.7 percent for Synercid and 60.0 percent for vancomycin. A total of 15.3 percent of patients discontinued treatment with Synercid and 9.5 percent with vancomycin due to an adverse event. This common respiratory tract infection poses a particular threat to already hospitalized patients. Catheter-Related Gram-Positive Bacteremia Antibiotic-resistant bacteria, particularly organisms such as methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant Staphylococcus epidermidis (MRSE) and isolates, present an acute danger to hospitalized patients requiring an indwelling catheter. In a clinical study conducted under the direction of Issam I. Raad, M.D., associate professor of medicine at The University of Texas, MD Anderson Cancer Center in Houston, Texas, USA, researchers found, in clinically and bacteriologically evaluable patients, response rates of 88 percent among those treated with Synercid, and 50 percent among those treated with vancomycin. Discontinuation rates due to an adverse event were 0.2 percent among patients treated with Synercid versus 0.15 percent among patients treated with vancomycin. About Synercid Synercid (quinupristin/dalfopristin), an investigational compound under development by Rhone-Poulenc Rorer, is an injectable streptogramin antibiotic made of two molecules, quinupristin and dalfopristin. When combined, they appear to create a synergistic bactericidal agent that may have the power to kill bacteria by inhibiting protein synthesis. Patients who were enrolled in the studies discussed above had infections caused by the following major Gram-positive pathogens: Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecium, and Streptococcus pneumoniae, including multidrug-resistant strains. Phase III clinical trials of Synercid are complete. Rhone-Poulenc Rorer anticipates filing for marketing clearance worldwide in the near future. The symposium was supported by an unrestricted grant from Rhone-Poulenc Rorer Inc., a global pharmaceutical company dedicated to improving human health. More information on: Rhone-Poulenc Rorer Inc., Synercid --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. 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