Exploratory Study of Impact of Oral Metronidazole, Vancomycin and Fidaxomicin on the Extent and Quantity of Host Carriage and Environmental Contamination With C. Difficile

Background and Significance:

C. difficile has emerged as one of the most important pathogens that threaten the health and quality of life for many populations. Data from different studies clearly indicate that shedding of viable spores and subsequent contamination of environmental surfaces play an important role in the transmission of C. difficile. We aim to perform an analysis of the impact of different oral antibiotic therapy on microbiologic kinetics in patients with C. difficile diarrhea, such as: shedding, colonization and environmental contamination. We believe data from this study can inform whether drug therapies may be used to interrupt disease transmission and to improve the infection control of C. difficile.

Purpose of the Study:

The purposes of this study are to 1) determine the impact of oral fidaxomicin, oral metronidazole and oral vancomycin on the baseline and the temporal variation of C. difficile isolated from specific body sites of a patient with microbiology-proven CDAD and 2) determine the impact of oral fidaxomicin, oral metronidazole and oral vancomycin on the baseline and the temporal variation of C. difficile isolated from targeted surfaces in a hospital room. , More specifically, we will establish the extent and quantity of C. difficile shedding, colonization and environmental contamination in patients who received oral fidaxomicin, oral metronidazole, or vancomycin and the duration that stool remains positive for C. difficile.

This study will prospectively study the role of the environment in Healthcare Associated Infections (HAIs) in the modern healthcare setting and will specifically address many limitations of previous studies. The study will use modern diagnostic and molecular methods to describe the microbiologic characteristics and concordance of cultures from the environment and from patient, describe temporal variation and relationship in the microbiologic profiles of cultures obtained from the environment and from the patient, assess confounders such as hand hygiene and quality of cleaning, and provide longitudinal follow up for subsequent outcomes.