Navigation Links
NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection
Date:7/9/2014

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched an early-stage clinical trial of CRS3123, an investigational oral antibiotic intended to treat Clostridium difficile (C. difficile) infection. CRS3123 (previously known as REP3123) is a narrow-spectrum agent that inhibits C. difficile growth while sparing normal intestinal bacteria.

The Phase I trial will enroll up to 30 healthy men and women ages 18 to 45 in a dose-escalation study to evaluate the investigational drug's safety and tolerability. Quintiles, through Dynport Vaccine Company, is conducting the study of CRS3123. The medication is being provided by its developer, Crestone, Inc., a pharmaceutical company based in Boulder, Colo.

C. difficile infection affects the digestive track with manifestations ranging from mild diarrhea to life-threatening colitis. Infection most commonly affects patients in hospitals or long-term care facilities and people who have taken antibiotics. Each year, roughly 250,000 people in the United States require hospital care for C. difficile infection and at least 14,000 people die from the infection, according to the U.S. Centers for Disease Control and Prevention (CDC). As a result, the CDC identified C. difficile as an urgent public health threat in its 2013 report on antibiotic resistance. Resistance to the antibiotics currently used to treat C. difficile is not yet a problem, but the bacteria spreads rapidly because it is naturally resistant to many drugs used to treat other infections. Recurrent infections pose a particular clinical challenge, especially those caused by a newer, stronger C. difficile strain, which result in up to 25 percent of patients needing additional therapy.

In the new clinical trial, participants will be randomly assigned into three groups of 10 participants each (8 participants will receive the investigational drug; 2 participants will receive a placebo pill). In the first group, participants will receive either 200 milligrams (mg) of CRS3123 or placebo twice daily for 10 days. Based on the review of safety data from this group, the study will progress to a second and then a third group of volunteers with a maximum possible dose of 600 mg twice daily. Participation in the trial will require an inpatient stay of 12 days to allow for monitored dosing and physical evaluations, including blood tests and urinalysis. Participants will be evaluated on an outpatient basis 18 and 29 days after receiving the first dose of the investigational drug. The study is expected to be completed by March 2015.


'/>"/>
Contact: Jennifer Routh
jennifer.routh@nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert  

Related medicine news :

1. IntegraGen launches ARISk test, a genetic screening tool for autism in high-risk children
2. Mayo Clinic launches whole genome breast cancer study
3. Original research papers on acute cardiovascular care: ESC launches EHJ-ACVC
4. UCLA launches first face transplantation program in western US
5. Georgia Tech launches HomeLab to help companies evaluate home health technologies
6. US Drug Watchdog Launches Now Calls Transvaginal Mesh A Disaster For 100,000's of US Women Recipients And Offers The Names and Contacts Of The Best Women Attorneys
7. K9 CarFence™ Launches as Newest Innovation in Pet Transportation
8. Golden Gate Opportunity: Moravia Worldwide Launches Bay Area Operation
9. 'Music Makes It Better' Campaign Launches with Justin Bieber, Victoria Justice, and The Band Perry
10. Fieldtex Products Launches a New Wellness Rewards Service for Companies
11. Recruiting for Good Launches Pet Philanthropy Program to Collaboratively Fundraise for Kitt Crusaders an Animal Rescue Organization
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection
(Date:10/13/2017)... ... 13, 2017 , ... Ellevate Network, the leading network for professional women, brought ... gender equality at their inaugural Summit in New York City in June. The event ... audience of over 3 million. To watch the Mobilize Women video, click here ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor ... on sciatica in a new episode of "Success Files," which is an award-winning ... innovation and investigates each subject in-depth with passion and integrity. , Sciatica occurs ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... ... 12, 2017 , ... The American College of Medical Informatics (ACMI) will present ... the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium ... Collen, a pioneer in the field of medical informatics, this prestigious award is presented ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. ... big data solutions, today announced that its MyDario product is expected to ... TV listings for when The Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, ... ...
(Date:9/22/2017)... 22, 2017 AVACEN Medical (AVACEN) announced that ... successfully helping those with the widespread pain associated with ... Amanda in Essex, England commented, ... hair, experiencing no sleep at all, tremendous pain, with ... cannot recommend [the AVACEN 100] enough, how this has ...
(Date:9/13/2017)... , Sept. 13, 2017   OrthoAtlanta has ... the Atlanta Football Host Committee (AFHC) for the 2018 College ... Jan. 8, 2018, at Mercedes-Benz Stadium in Atlanta, ... of the AFHC "I,m In" campaign, participating in many activities ... ...
Breaking Medicine Technology: