New Trial at UH Rainbow Evaluating Treatment to Prevent Recurrent C difficile Infection in Children
August 30, 2018
UH Clinical Update - August 2018
The incidence of C. difficile infection is increasing in children.
“We don’t have a good sense of why it’s on the rise in kids,” says Thomas Sferra, MD, Division Chief of Pediatric Gastroenterology at UH Rainbow Babies & Children’s Hospital. “But we do know that it used to be common just in hospitalized patients, but now we’re seeing it more frequently in ambulatory patients who don’t have any risk factors. That’s become a big problem.”
One of the big complications of C. difficile infection, Dr. Sferra says, is the risk of recurrence.
“Once you have one recurrence, then you have multiple recurrences, and those have significant morbidity,” he says.
To address this problem, Dr. Sferra and his team are leading a clinical trial at UH Rainbow evaluating a drug designed to prevent C. difficile recurrence in children.
“Current treatments are effective, but they’re not designed to prevent recurrence,” he says. “The drug we’re studying, bezlotoxumab, is a one-time intravenous infusion of an antibody that has been shown to decrease recurrence. We think it’s going to be safe, because it’s been shown to be very safe in adults. We believe that it will decrease the risk of recurrent infection.”
The trial is a Phase 3, randomized, placebo-controlled, parallel-group, multi-site, double-blind trial evaluating the pharmacokinetics, safety, tolerability and efficacy of a single infusion of bezlotoxumab in pediatric participants from 1 to C. difficile infection.
At screening, eligible participants must have suspected or confirmed C. difficile infection and be receiving or planning to receive a 10- to 21-day course of antibacterial drug treatment for the condition.
“Participants should have a positive initial stool test for C. difficile, then we will go to confirm that,” Dr. Sferra says.
Once the diagnosis has been confirmed, participants will be randomly assigned to receive a single intravenous infusion of either bezlotoxumab or placebo. After receiving the study infusion, participants will be followed for 12 weeks.