(Press-News.org) 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.
INFORMATION:
Resources
Information about this clinical trial is available at ClinicalTrials.gov using the identifier NCT02106338. NIAID is also testing CRS3123 in a single oral dose Phase 1 trial.
Information about that trial can also be found on ClinicalTrials.gov using the identifier NCT01551004.
The study is being conducted by Quintiles through Dynport Vaccine Company under contract HHSN272200800024C.
See "How a Drug Becomes a Drug" video.
Shahida Baqar, Ph.D., program officer, and Stephanie Zafonte, M.S.N., R.N., nurse consultant/clinical project manager, in the Enteric and Hepatic Diseases Branch of NIAID's Division of Microbiology and Infectious Diseases, are available for comment.
Contact
To schedule interviews, please contact Jennifer Routh, (301) 402-1663, jennifer.routh@nih.gov.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
NIH...Turning Discovery Into Health®
NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection
2014-07-09
[Attachments] See images for this press release:
ELSE PRESS RELEASES FROM THIS DATE:
The impact of big data on health care: Health Affairs' July issue
2014-07-09
Big data can yield big savings, if they are used in the right ways. David W. Bates of the Brigham and Women's Hospital and coauthors analyzed six use cases with strong opportunities for cost savings—high-cost patients; readmissions; triage; decompensation (when a patient's condition worsens); adverse events; and treatment optimization when a disease affects multiple organ systems. They suspect that cost-savings benefits will vary widely, though the current costs associated with all six scenarios will be significant. The authors suggest that using analytics for multiple ...
Discovery of new drug targets for memory impairment in Alzheimer's disease
2014-07-09
VIDEO:
This is a movie showing how the reactive astrocytes in the brains of Alzheimer's disease model produce the inhibitory transmitter GABA by the enzyme MAO-B and release GABA through the...
Click here for more information.
Alzheimer's disease, which is the most common cause of dementia, is fatal and currently, there is no cure. In Alzheimer's disease, brain cells are damaged and destroyed, leading to devastating memory loss. It is reported that 1 in 8 Americans aged 65 or over ...
Neuroprotective effects of low concentration of lithium
2014-07-09
Lithium, as a neuroprotective agent, benefits for neuronal survival. Recent cDNA array studies have demonstrated that mood stabilizer lithium exhibits neuroprotective effects through multiple targets. Dr. Riadh Nciri and his team, Purpan Medicine Faculty, Paul Sabatier University, France, exposed SH-SY5Y cells to 0.5 mmol/L lithium carbonate for 25-50 weeks and then detected the expression levels of some neurobiology related genes and post-translational modifications of stress proteins in SH-SY5Y cells. cDNA arrays showed that pyruvate kinase 2 (PKM2) and calmodulin 3 expression ...
Filiform needle acupuncture versus antidepressant drugs for poststroke depression
2014-07-09
Whether acupuncture or antidepressant drugs exhibit better therapeutic effects on poststroke depression remains disputed. The effectiveness of acupuncture for poststroke depression can be evaluated by evidence-based medicine studies, which provide evidence for clinical application. Systematic review or meta-analysis studies have demonstrated that early acupuncture is superior to conventional western medicine in the treatment of poststroke depression. However, high-quality literatures are needed to further validate the effectiveness of acupuncture for poststroke depression. ...
What aggravates hippocampal neuronal injury in acute cerebral ischemia?
2014-07-09
Activation of extracellular signal-regulated kinase 1/2 has been demonstrated in acute cerebral ischemia. Yaning Zhao and her colleagues, Hebei United University, China induced transient whole-brain ischemia by four-vessel occlusion in normal and diabetic rats and intravenously injected diabetic rats with extracellular signal-regulated kinase 1/2 30 minutes before ischemia as a pretreatment. Results showed that during the pathological progression of cerebral ischemia/reperfusion in rats, activation of extracellular signal-regulated kinase 1/2 exhibits protective effect ...
Depression in AMD patients with low vision can be halved by integrated therapies
2014-07-09
SAN FRANCISCO – July 9, 2014 – The first clinical trial to examine integrated low vision and mental health treatment has shown that the approach can reduce the incidence of depression by half among people with low vision due to age-related macular degeneration (AMD). The results of the study were published online today in Ophthalmology, the journal of the American Academy of Ophthalmology.
Low vision is a visual impairment that interferes with a person's ability to perform everyday tasks and cannot be corrected with glasses, contact lenses, medicine or surgery. A common ...
Rehabilitation helps prevent depression from age-related vision loss
2014-07-09
Depression is a common risk for people who have lost their vision from age-related macular degeneration (AMD), but a new study shows that a type of rehabilitation therapy can cut this risk in half. The study was funded by the National Eye Institute (NEI), part of the National Institutes of Health.
"Our results emphasize the high risk of depression from AMD, and the benefits of multi-disciplinary treatment that bridges primary eye care, psychiatry, psychology, and rehabilitation," said Barry Rovner, M.D., a professor of psychiatry and neurology at the Sidney Kimmel Medical ...
Researchers led by Stanford engineer figure out how to make more efficient fuel cells
2014-07-09
Solar power and other sources of renewable energy can help combat global warming but they have a drawback: they don't produce energy as predictably as plants powered by oil, coal or natural gas. Solar panels only produce electricity when the sun is shining, and wind turbines are only productive when the wind is brisk.
Ideally, alternative energy sources would be complemented with massive systems to store and dispense power – think batteries on steroids. Reversible fuel cells have been envisioned as one such storage solution.
Fuel cells use oxygen and hydrogen as fuel ...
Children on dairy farms less likely to develop allergies
2014-07-09
The occurrence of allergic diseases has risen dramatically in Western societies. One frequently cited reason is that children are less exposed to microorganisms and have fewer infections than previous generations, thereby delaying maturation of the immune system.
A study by researchers at Sahlgrenska Academy, University of Gothenburg, monitored children until the age of three to examine maturation of the immune system in relation to allergic disease. All of the children lived in rural areas of the Västra Götaland Region, half of them on farms that produced milk.
Lower ...
USC scientists discover immune system component that resists sepsis in mice
2014-07-09
Molecular microbiologists from the Keck School of Medicine of the University of Southern California (USC) have discovered that mice lacking a specific component of the immune system are completely resistant to sepsis, a potentially fatal complication of infection. The discovery suggests that blocking this immune system component may help reduce inflammation in human autoimmune and hyper-inflammatory diseases such as rheumatoid arthritis and Type 2 diabetes.
The study was published online on June 23 in The Journal of Experimental Medicine, a leading peer-reviewed scientific ...