NIAID launches clinical trial of new C. diff treatment
The treatment, known as CRS3123, is a narrow-spectrum agent that inhibits C. diff growth while sparing normal bacteria in the intestine.
The Phase I trial will use up to 30 healthy volunteers ages 18-45 in a dose-escalation study. The trial will evaluate CRS3123's safety and tolerability.
Participants in the study will be randomly assigned into three groups of 10 people each, with eight receiving the investigational drug and two taking a placebo. A second and third group will be tested based on a review of the safety data from the first.
Quintile, through Dynport Vaccine, Co., is conducting the study. Its developer, Crestone, Inc., is providing the medication.
The study is expected to be complete by March of next year.
The Centers for Disease Control and Prevention declared C. diff a public health threat in 2013. Patients usually come into contact with C. diff while hospitalized and receiving intravenous treatment. Infection can cause diarrhea, inflammation of the gut and, in some cases, death.
Approximately 250,000 people are hospitalized in the U.S. every year from C. diff infection.