Clostridium difficile infection has become a major healthcare problem
Clostridium difficile—also known as C. difficile or C. diff—is a rod-shaped, Gram-positive bacterium which can cause gastrointestinal infections. Transmitted through spores, the disease mainly affects people with weak immune systems. Key risk factors therefore include advanced age, hospitalization, and the intake of medicines that damage the gut flora, such as antibiotics.
Up to 40 percent of patients develop severe forms of CDI, manifested in colonic inflammation, fever, high white-blood-cell count, and/or impaired kidney function. Of this group, about one-fourth are admitted to intensive care and may undergo major surgery due to complications such as ileus (intestinal blockage), toxic megacolon (intestinal dilatation), colonic perforation, or refractory colitis. Usually referred to as “severe and complicated CDI”, these conditions can be fatal for patients as there is no effective cure.
Having identified CDI as a threat to public health with limited treatment options, the U.S. FDA has included C. diff in its list of pathogens where related therapies may be designated as Qualified Infectious Disease Products (QIDP) under the GAIN Act (GAIN: Generating Antibiotics Incentives Now).
Public U.S. statistics recently identified CDI as one of the primary causes of healthcare-associated infections, ranking even above MRSA. In 2011, almost half a million Americans were newly infected; over 29,000 patients died within 30 days of diagnosis—more than twice the number of annual deaths from HIV/AIDS.
Recurrences have tripled over the past decade, due to increased (mis-) use of antibiotics, the growing numbers of immunosuppressed and/or elderly patients, and the emergence of new, hypervirulent C. diff strains. The latter now account for over 50 percent of cases. At present, 20 to 30 percent of CDI patients in the U.S. and Europe are expected to relapse—an alarming development.
For 2021, experts forecast over 1.5 million CDI infections for the U.S. and Europe combined and even higher numbers for Asia. The threat to public health is clearly increasing.
As almost all available analyses have focused on inpatients, the total cost burden on the healthcare system is likely to be underestimated. After all, a sizeable part of it has yet to be quantified: Figures do not include patients discharged to long-term care, the numerous instances of CDI onset in long-term care facilities, recurrent episodes, and people treated in outpatient settings. Recurrences in particular are associated with excessive cost, mostly attributable to significantly extended hospital stays.