Ortho-McNeil Initiates First-Of-Its-Kind Skin Infection Registry

Main Category: Dermatology
Also Included In: Infectious Diseases / Bacteria / Viruses
Article Date: 07 Aug 2008 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The USA's first, prospective registry of complicated skin and soft tissue infections (cSSTIs), known as SSTIR (the Skin and Soft Tissue Infection Hospital Registry), has begun enrolling patients. The SSTIR, plans to enroll more than 1,200 hospitalized patients by the end of this year, and is designed to better understand treatment patterns and provide data to help improve patient outcomes. The registry is sponsored by Ortho-McNeil, division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

More than 50 hospitals nationwide will participate in this prospective, multi-center registry, which will comprehensively characterize the four major types of cSSTIs: diabetic foot infections, surgical site infections, deep soft tissue abscesses and cellulitis (an infection of tissue under the skin). In addition, the study will observe patient management in the hospital setting, including selection and timing of antibiotic treatment, changes in treatment regimen, outcomes, and economic impact.

"Physicians are treating more and more patients with complicated skin infections in hospitals across the U.S., and the emergence of resistant pathogens has made the situation even more complex," said Susan Nicholson, M.D., Therapeutic Area Leader, Internal Medicine, Ortho-McNeil, division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. "This data will give physicians insight into how to manage these difficult-to-treat infections and understand current treatment patterns in order to provide consensus on how best to care for patients."

Complicated skin and soft tissue infections account for almost 10 percent of all hospital admissions in the U.S. The most common types of cSSTIs are post-operative surgical site infections, which represent up to 25 percent of all hospital infections. Cellulitis and soft tissue abscesses are among the most common reasons for emergency department visits.

According to the National Institutes of Health, 111,000 people with diabetes are hospitalized with foot infections each year, and as many as 3.09 million adults will develop a diabetic foot infection in their lifetime.

The increased incidence of one of the most common resistant bacteria that are causing cSSTI, methicillin-resistant Staphylococcus aureus (MRSA), poses a significant challenge and burden to the U.S. health care system. Despite the high incidence of cSSTIs, a limited understanding remains and a wide variety of treatment options are used which often affect patient outcomes.

The emergence of resistant bacteria has created a need for new antibiotics and treatment strategies. As such, treatment choices made by physicians can significantly impact how patients with cSSTI respond to care.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.