Minocycline/Rifampin-Impregnated Catheters Proven Clinically Effective in Preventing and Combating Potentially Fatal Bloodstream Infections in Two New Studies

Antimicrobial technology unique to Cook's Spectrum® catheters shown to be most effective in preventing infections that kill over 91,000 Americans a year

BLOOMINGTON, Ind.--(BUSINESS WIRE)--Feb 5, 2009 - Minocycline/rifampin-impregnated catheters are a critical component in modern health care practices designed to eliminate potentially fatal catheter-related bloodstream infections (CRBSIs) that affect 250,000 Americans a year, according to recently released clinical data from the Society of Critical Care Medicine's 38th Critical Care Congress. The first set of data reveal that an over-the-wire exchange of an infected central venous catheter (CVC) for a CVC impregnated with minocycline and rifampin, which are two antibiotic drugs that act together to dramatically reduce the risk of infections, can more quickly help eliminate an existing infection in cancer patients than currently recommended procedures. The second, a first ever head-to-head study that lasted 46 months, revealed that minocycline/rifampin-impregnated CVCs are nearly twice as effective at preventing CRBSIs than second generation CVCs coated with a chlorhexidine/silver sulfadiazine solution.

On February 2, 2009, Issam I. Raad, M.D., professor and chairman of infectious diseases at The University of Texas M. D. Anderson Cancer Center, presented data from a study of more than 100 cancer patients that had developed CRBSIs. The results demonstrated that exchanging an infected CVC for a CVC impregnated with minocycline and rifampin was significantly more effective at resolving the potentially fatal symptoms associated with CRBSIs, including acute fever and bacteremia, within 72 hours of insertion.

“This study is a significant development in advancing the procedures and technologies that aim to eliminate CRBSIs, a hospital-acquired infection that afflicts 250,000 Americans annually,” said Charles McIntosh, M.D., chief medical science and technology officer for Cook Medical, which manufactures the advanced minocycline/ rifampin-impregnated Spectrum catheter. “Dr. Raad's study is important, as it offers additional clinical evidence on how to employ advanced technology to resolve CRBSIs in cancer patients.”

In the study, 40 patients had infected CVCs that were exchanged for CVCs impregnated with minocycline and rifampin, and 80 patients had the infected CVCs removed. Ninety-five percent of patients receiving the antimicrobial-impregnated CVCs reported eradication of bacteremia within 72 hours, with no cases of relapse or infection-related deaths. Comparatively, 88 percent of participants in the CVC removal group exhibited no clinical signs of bacteremia within 72 hours. There were six cases of relapse or infection-related deaths during the hospital stay in the CVC removal group.

“These findings suggest that there is a more effective way to manage CRBSIs in cancer patients than current guidelines, which recommend the removal of the infected CVC or replacing it with another CVC inserted at a new access site,” said Dr. Raad. “Although removing a CVC that has led to a CRBSI can help manage the infection, this is not always practical for cancer patients because there is additional cost and risk to the patient associated with replacement of the catheter at a new access site. Exchanging a CVC for an minocycline and rifampin-impregnated CVC not only reduces cost and risk associated with a new access site, but demonstrates superior clinical outcomes for this high risk group of patients.”

In another study presented at the Congress by Craig M. Coopersmith, M.D., associate professor of Surgery and Anesthesiology and co-director of the Surgical Intensive Care Unit at Washington University School of Medicine in St. Louis, CVCs impregnated with minocycline and rifampin were proven to be significantly more likely to prevent CRBSIs than second generation CVCs coated with a solution of chlorhexidine and silver sulfadiazine. The 46-month study, a first ever head-to-head comparison, revealed that only 1.4 CRBSIs per 1,000 catheter days developed in patients who had received CVCs impregnated with minocycline and rifampin, versus 2.7 infections per 1,000 catheter days in patients who had received the second generation chlorhexidine/silver sulfadiazine-coated CVCs.

One of the six hospital-acquired infections the U.S. Department of Health & Human Services aims to eradicate in its recently announced five-year plan, CRBSIs are responsible for 250 deaths daily in the United States alone. CVCs impregnated with minocycline and rifampin are clinically proven to be 12 times less likely to result in a CRBSI1 than catheters coated with antiseptic or invasive agents. In addition, the combination of minocycline and rifampin is proven2 to reduce the risk of bacteria developing antibiotic resistance to the drugs used in the impregnated catheters.

Dr. Raad is the co-inventor of the synergistic pairing of the antibiotics minocycline and rifampin that are impregnated within the catheter material of the Cook Spectrum® catheter. His institution receives a royalty payment based upon Cook's license to use this patented technology.

About Cook Medical:

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.

1 Darouiche RO, Raad II, Heard SO, et al. A comparison of two antimicrobial-impregnated central venous catheters. N Engl J Med. 1999;340(1):1-8.

2 Raad I, Ramos E, et al. Process & technology: complimentary, not mutually exclusive. Presented at the Society for Healthcare Epidemiology of America's (SHEA) 18th Annual Scientific Meeting; April 5-8, 2008.

 

Contact: Cook Medical
Marsha Dawes, 812-339-2235, ext. 2750
Public Relations Coordinator
Marsha.Dawes@cookmedical.com
or
Racepoint Group, Inc.
Cheri Keith, 781-487-4672
ckeith@racepointgroup.com

 

Posted: February 2009

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