1. Overdiagnosis of Clostridium difficile Infection in the Molecular Test Era.
- Author
-
Polage, Christopher R, Gyorke, Clare E, Kennedy, Michael A, Leslie, Jhansi L, Chin, David L, Wang, Susan, Nguyen, Hien H, Huang, Bin, Tang, Yi-Wei, Lee, Lenora W, Kim, Kyoungmi, Taylor, Sandra, Romano, Patrick S, Panacek, Edward A, Goodell, Parker B, Solnick, Jay V, and Cohen, Stuart H
- Subjects
Humans ,Clostridium Infections ,Cross Infection ,Bacterial Toxins ,Anti-Bacterial Agents ,Hospitalization ,Cohort Studies ,Prospective Studies ,Polymerase Chain Reaction ,Aged ,Middle Aged ,United States ,Female ,Male ,Medical Overuse ,Clostridioides difficile ,Emerging Infectious Diseases ,Prevention ,Biodefense ,Clinical Research ,Digestive Diseases ,Infectious Diseases ,Vaccine Related ,Infection ,Good Health and Well Being ,Clinical Sciences ,Opthalmology and Optometry ,Public Health and Health Services - Abstract
ImportanceClostridium difficile is a major cause of health care-associated infection, but disagreement between diagnostic tests is an ongoing barrier to clinical decision making and public health reporting. Molecular tests are increasingly used to diagnose C difficile infection (CDI), but many molecular test-positive patients lack toxins that historically defined disease, making it unclear if they need treatment.ObjectiveTo determine the natural history and need for treatment of patients who are toxin immunoassay negative and polymerase chain reaction (PCR) positive (Tox-/PCR+) for CDI.Design, setting, and participantsProspective observational cohort study at a single academic medical center among 1416 hospitalized adults tested for C difficile toxins 72 hours or longer after admission between December 1, 2010, and October 20, 2012. The analysis was conducted in stages with revisions from April 27, 2013, to January 13, 2015.Main outcomes and measuresPatients undergoing C difficile testing were grouped by US Food and Drug Administration-approved toxin and PCR tests as Tox+/PCR+, Tox-/PCR+, or Tox-/PCR-. Toxin results were reported clinically. Polymerase chain reaction results were not reported. The main study outcomes were duration of diarrhea during up to 14 days of treatment, rate of CDI-related complications (ie, colectomy, megacolon, or intensive care unit care) and CDI-related death within 30 days.ResultsTwenty-one percent (293 of 1416) of hospitalized adults tested for C difficile were positive by PCR, but 44.7% (131 of 293) had toxins detected by the clinical toxin test. At baseline, Tox-/PCR+ patients had lower C difficile bacterial load and less antibiotic exposure, fecal inflammation, and diarrhea than Tox+/PCR+ patients (P
- Published
- 2015