Investigation by Pfizer aims to combat Clostridioides difficile
Hackensack Meridian Health, New Jersey’s largest and most comprehensive health network, is joining a massive clinical trial to combat one of the most problematic infections in a health-care setting: Clostridioides difficile, or C. diff.
The Hackensack Meridian Health Research Institute will host two of Pfizer’s sites for the BEETHOVEN study, which is investigating a vaccine to prevent C. diff infections.
Hackensack University Medical Center and Jersey Shore University Medical Center physicians aim to enroll 1,000 participants - making it the largest-ever clinical trial for Hackensack Meridian Health.
“This is a landmark investigation for the health-care industry, and we are glad to do our part for it,” said Ihor Sawczuk, M.D., FACS, president of Academics, Research, and Innovation at the network, the founding chair of HMHRI, and associate dean of Clinical and Research Integration at the Hackensack Meridian School of Medicine.
BEETHOVEN is a Phase 3, placebo-controlled, double-blinded, and randomized study whose purpose is to learn about how effective, safe, and tolerable the C. diff vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older. The study is taking place at more than 129 sites in four countries, with an overall goal of enrolling 32,000 participants. The trial is designed to characterize the safety and efficacy of the vaccine in adults 65 years or older.
C. diff is a bacterium which most often causes diarrhea and colitis, or inflammation of the colon, but which can be serious enough to cause serious disease and even death, especially in those with weakened immune systems, according to the CDC. Approximately half a million infections are caused each year by the germ, the federal agency adds.
C. diff infection is more common among patients in clinical settings like hospitals and nursing homes, because patients can carry and transmit the bacteria. C. diff germs spread from person to person via fecal matter, but the bacteria are often found in the environment, as well. Finding C. diff germs in homes is not unusual, even when no one in the home has been ill with the infection. The bacteria are hardy as well; when they are outside the body, they become spores which have a protective coating allowing them to live for months or years on surfaces and in the soil.
To qualify for the study, participants must not have previously had C. diff and have one of the following risk factors for infection:
- 65 years of age or older
- Received antibiotics in the last three months
- Been hospitalized at least once or had two ER visits in the last year
- Had 10 or more healthcare visits in the last year
- Are scheduled to be hospitalized or have elective surgery
This study will include a two-dose regimen (six months) of an adjuvanted vaccine for preventing C. difficile in an older population. Subjects will be followed for 3.5 years and will complete e-diary check ins and answer questions about their interim health and medications.
Bindu Balani, M.D., associate professor of Internal Medicine at the Hackensack Meridian School of Medicine and affiliate associate member of the Center for Discovery and Innovation, is the principal investigator at HUMC and she will be working with Dr. Ashley Eunhye Kang and Dr. Arunima Sarkar. At Jersey Shore University Medical Center, Dr. Anna Kufelnicka, Dr. Jose Fune, and Dr. Alex Lazo-Vasquez will be the sub-investigators overseeing the study.