www.CriteriumInc.com
MARCH 2011

 This Month's Clinical Focus:
INFECTIOUS DISEASE


 New Guidelines Issued for Drug-Resistant Staph Infections (MRSA)

Infectious disease specialists seek to standardize treatment for potentially deadly germ.  An infectious disease association has released the first national guidelines for the treatment of potentially deadly methicillin-resistant Staphylococcus aureus (MRSA) infections.

Initially found in healthcare facilities, MRSA infections have become an increasing issue for healthy people outside hospitals. They now represent 60 percent of all skin infections treated in emergency rooms. In most cases, MRSA -- strains of staph bacteria resistant to all first-line antibiotics -- causes painful, red swollen bumps that are frequently mistaken for spider bites and that can usually be treated successfully if caught early.

Invasive MRSA -- an infection that spreads from the skin into other parts of the body -- is less common, but far more serious. About 94,360 cases of invasive MRSA were reported in the United States in 2005, and more than 18,000 of those patients died -- a figure that surpassed those dying that year of AIDS.

Currently, there are wide variations in treatment approaches -- something the new guidelines from the Infectious Diseases Society of America (IDSA) hopes to address.

"MRSA has become a huge public health problem and physicians often struggle with how to treat it," guidelines lead author Dr. Catherine Liu, an assistant clinical professor in the Division of Infectious Diseases at the University of California, San Francisco, said in an IDSA news release. "These guidelines establish a framework to help physicians determine how to evaluate and treat uncomplicated as well as invasive infections."

Topics covered in the guidelines include how to manage skin and soft tissue MRSA infections, treating recurrent skin infections, using antibiotics for treating MRSA, managing invasive infections and treating newborns infected with it.

The guidelines have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians and the American Academy of Pediatrics.

SOURCE: Infectious Diseases Society of America, news release, Jan. 5, 2011, article by By Robert Preidt


 Infectious Disease Experts Call for Increased Focus on Hepatitis C

Rates among drug users have not plummeted like HIV, study finds. Among injection drug users, new cases of HIV infection have declined dramatically in the past two decades, but the number of new infections from the hepatitis C virus have dropped only a small amount, a new study reports.

The findings suggest that efforts -- such as needle exchange programs and substance abuse treatment -- to prevent blood-borne transmission of infectious diseases have been successful against HIV but more needs to be done to reduce the transmission of hepatitis C virus (HCV), according to the study's leader, Shruti H. Mehta of the Johns Hopkins School of Public Health.

The researchers noted that HCV is nearly 10 times more transmissible by sharing needles than HIV. Sharing a needle just once can be enough to transmit HCV.  The results suggest that "current prevention efforts delay but do not prevent HCV at the population level and will need to be further intensified to reduce risk of HCV infection to the level of HIV," the researchers wrote. They called for expansion of efforts on both the prevention and the treatment fronts to reduce the reservoir of HCV-infected injection drug users.

The study, which looked at infection rates among injection drug users in Baltimore over a 20-year span, found dramatic decreases in new HIV infections: from 5.5 cases per 100 person years in 1988-1989 to two per 100 in 1994-1995, and to zero cases in 1998 and 2005-2008.

Reductions in new HCV infections were not as dramatic: from 22 cases per 100 person years in 1988-1989 to 17.2 per 100 in 1994-1995, to 17.9 in 1998 and to 7.8 in 2005-2008.

Overall, new cases of HCV appeared to decrease only among younger injection drug users who had recently starting using the drugs, the study found.

SOURCE: Journal of Infectious Diseases, news release, Jan. 31, 2011; article by Robert Preidt


 If you want to accelerate your clinical trials,
 you need to change the workflow paradigm.

Criterium knows resources are precious, time is the enemy, and results are paramount. Information Management done right is the key to successful trials. Our user-friendly technologies are integrated into all aspects of our clinical development services for improved efficiencies. And a talented in-house staff that is committed to the professional support of our clients' individual and particular needs is the backbone of our processes for maximum client outcomes.

 We have managed successful clinical trials
 for over 20 years.
Of particular interest to you would be our experience with 
INFECTIOUS DISEASE and VACCINE TRIALS, including:
Bacterial Vaginosis, Malaria, Fungal Infections, Osteomyelitis, Anemia, Sepsis, Skin and Soft Tissue Infections, HIV/Esophageal Candidiasis, Plasmapheresis, Rotavirus, Sepsis, Yeast Infections, Chronic Bacterial Prostatitis, Herpes, Influenza, Genital Warts, Chronic Wounds, Skin and Soft Tissue Infections, Infections of Traumatic Lesions, CAP, Pneumonia in Children, MRSA, C. Difficle
 
 We have several proprietary technology solutions that are proven to improve your clinical trial results.
Contact: John Hudak, President at
jmhudak@criteriuminc.com

WHAT'S NEW AT CRITERIUM:
 

CRITERIUM, Inc. Global CRO
Celebrates 20th Anniversary!


OUR WHITE PAPERS
   Critical Clinical Research Factors in the Down Economy
By Lawrence Reiter, Ph.D.
   The Evolution of the Data Management Role: The Clinical Data Liaison
By Mary Stefanzick
   India: A Target-Rich Environment
By Ronny Schnel

OUR VIDEOS
   The DIA Interview
Featuring Lawrence Reiter, Ph.D.

 
Addressing the Challenge of Finding Investigators for Clinical Trials
Featuring Kabelo Pududu
   The Clinical Data Liaison: The Key to Better, Faster Clinical Trials
Featuring John M. Hudak

OUR PODCASTS
 

 NEW!!  The Site-Centric CRO: Best Practices   
Featuring Ed Jahn, Clinical Ops Specialist & Jaime Hudak, CDL

 Science is Greater than the Economy   
Featuring Lawrence Reiter, Ph.D.

 The Clinical Data Liaison: The Key to Better, Faster Clinical Trials
Featuring John M. Hudak

   Agile Clinical Trials and the Use of Real-Time Data
Featuring John M. Hudak

OUR PUBLICATIONS
 

 NEW!!  No Longer Lost In Translation
- Dr. Gavin Leong
PharmaVOICE Magazine

 Predictions for the 2010 Pharma Market
- Lawrence Reiter, Ph.D.

Journal for Clinical Studies


 NEW!!  Maintaining Clinical Operations: It's Just Good Business 
- Lawrence Reiter, Ph.D.

PharmaVoice View on Clinical Operations

   EDC Implementation 
- Greg Bailey

PharmaVOICE, View on
E-Solutions
   Going Global 
- John M. Hudak

Future Pharmaceuticals
   Trials Limber Up 
- John M. Hudak

International Clinical Trials Magazine

OUR PRESENTATION
   Criterium Capabilities Presentation

OUR BROCHURE
 

 Criterium -
Connect - Communicate - Control

 

 

 

 GET TO KNOW US!

 CALL US FOR COMPETITIVE BIDS ON YOUR NEXT PROJECT! 
FULL-SERVICE RESEARCH - TRIAL RESCUE SERVICES - PRO
JECT & DATA MANAGEMENT - BIOSTATISTICS - SITE SELECTION & MANAGEMENT - PROTOCOL DESIGN & CONSULTING - CLINICAL & MEDICAL MONITORING - CRF DESIGN   IVR / IWR - FAX & ELECTRONIC DATA CAPTURE - MEDICAL WRITING - SAFETY - REGULATORY CONSULTING -- MORE!
 

About Criterium Inc.  Criterium Inc. www.criteriuminc.com is a global, full-service, technology-driven contract research organization that offers a unique mix of high-quality, innovative clinical research solutions for the biopharmaceutical, pharmaceutical, medical device, and CRO industries.