N Engl J Med ; Clostridium difficile infection is the leading cause of health care—associated diarrhea, and the bacterium can also be carried asymptomatically. The objective of this study was to identify host and bacterial factors associated with health care—associated acquisition of C. Full Text of Background We conducted a month prospective study in six Canadian hospitals in Quebec and Ontario.

Demographic information, known risk factors, potential confounding factors, and weekly stool samples or rectal swabs were collected. Pulsed-field gel electrophoresis PFGE was performed on C. Levels of serum antibodies against C. Full Text of Methods A total of patients were included in the study; 2. Older age and use of antibiotics and proton-pump inhibitors were significantly associated with health care—associated C. Hospitalization in the previous 2 months; use of chemotherapy, proton-pump inhibitors, and H 2 blockers; and antibodies against toxin B were associated with health care—associated C.

Among patients with health care—associated C. Full Text of Results In this study, health care—associated C. The NAP1 strain was predominant among patients with C. Funded by the Consortium de Recherche sur le Clostridium difficile.

Full Text of Discussion Clostridium difficile is the leading cause of health care—associated infectious diarrhea. Risk factors for C. The genes encoding toxins A and B tcdA and tcdB, respectively are on the The objective of this study was to examine the relationships among host risk factors, bacterial virulence, and host immunity in health care—associated C.

Six Canadian, university-affiliated hospitals participated in the study: The research protocol was approved by each institutional review board. From March 6,to June 25,all consecutive patients 18 years of age or older admitted on selected units were asked to participate in the study. The selected units were those with a historically high or low incidence of C. All participants gave written informed consent. Diarrhea was defined as three loose stools within at least one hour period.

Recurrence was defined as a second episode of C. An episode of C. Data on demographic information, known risk factors, and potential confounding factors were collected. In particular, information about the use of various medications during the 8 weeks before, as well as during, hospitalization was collected for all patients. For patients in whom health care—associated C. Patients were followed daily until ward discharge, death, or withdrawal from the study.

Patients were contacted 60 days after discharge to determine whether diarrhea had developed in the interim. Outcomes studied were recurrence of C. For any death, two physicians judged independently whether health care—associated C. In the case of a disagreement, a consensus was reached.

Rectal swabs or stool samples for toxigenic C. A rectal swab was obtained if a stool sample could not be procured on the scheduled day of sampling. Serum samples were obtained on admission for measurement of antibody levels. Detection of antibodies against toxins A and B was performed with the use of purified recombinant fragments containing the carboxy terminal of toxin A residues to and toxin B residues to of C.

Epidemiologic and molecular data were collected and interpreted independently. Eligible patients who decided not to participate and those who did participate were compared with respect to mean age and sex. Participants were categorized into four groups, according to status with respect to C.

The cumulative incidences of health care—associated C. To study the association between potential risk factors and health care—associated C. The control group for health care—associated C. To ensure that case patients and control patients had similar risks of exposure to C. The length of stay was defined as the time from admission until diagnosis of C.

Univariate and multivariate conditional logistic-regression models were used, with health care—associated C. Analyses included all controls who could be matched to at least one case patient; patients without C. In analyses of health care—associated C. The prespecified covariates included age, sex, score on the Charlson comorbidity index, 22 status with respect to previous hospitalization, serologic data, and status with respect to medication use in the 8 weeks before hospitalization or before C.

Medication use was treated as a dichotomous covariate rather than as time dependent because we had data on dates of medication use only for patients in whom health care—associated C. The models included antibiotic use as a single summary variable indicating exposure to any antibiotic.

An unconditional logistic-regression model with adjustment for length of stay and hospital was used to determine the association between risk factors and health care—associated C. This strategy was chosen because of the limited numbers of study participants and matched case—control pairs among patients with positive cultures for C.

In this analysis, three patients with infection and one patient with colonization were excluded on the basis of missing covariate information. Each hospital had between 1 and 4 study units, for a total of 14 units: Each unit had between 23 and 49 beds. The number of admissions ranged from to per year. A total of 12, patients were approached about participation, of whom were not eligible.

Among the eligible patients, Among patients who became infected with C. Six other patients with a history of C. A total of of the patients In all, patients Eligible nonparticipants were younger than participants, by 0. Participants who could not be evaluated were older than those who could be evaluated, by 1. Of the patients who could be evaluated, 4. The incidences of health care—associated C. Table 1 Table 1 Baseline Characteristics of the Study Patients and Characteristics of Samples and Pathogens, According to Clinical Status.

As compared with the other groups, patients with health care—associated C. Figure 2 Figure 2 Times to Health Care—Associated Clostridium difficile Infection and Colonization during Hospitalization. Analyses of the cumulative probability of C. The time to health care—associated C. For example, colonization had occurred in 2. Among the patients with health care—associated C. None of the patients required colectomy. Twenty-nine of the infected patients Among the 60 excluded patients who became infected with C.

Laboratory analyses were performed on available isolates. Patients with health care—associated C. Stool samples obtained from 3 patients with C.

Isolates were available for Older age, use of antibiotics, and use of proton-pump inhibitors were all significant risk factors for health care—associated C. Hospitalization in the previous 2 months; use of chemotherapy, proton-pump inhibitors, or H 2 blockers; and the presence of antibodies against toxin B were significant risk factors for health care—associated C. Among patients with positive cultures for C. Older age, use of antibiotics, and use of proton-pump inhibitors were significantly associated with health care—associated C.

Our study not only confirms the finding in other studies that older age is a risk factor for health care—associated C. Use of antibiotics or proton-pump inhibitors was also found to be a risk factor for health care—associated C. We measured levels of antibodies against toxins A and B at the time of admission and did not find a significant association between these levels and subsequent health care—associated C.

Other studies have examined levels of antibodies against toxin A within a certain period before or after infection and colonization but not at the time of admission, and therefore they are not comparable to our study. The factors we found to be associated with health care—associated C. Previous hospitalization suggests previous exposure to C. Chemotherapy, proton-pump inhibitors, and H 2 blockers may disrupt the bowel flora and allow for C. Antibodies against toxin B may permit colonization by C.

Antibodies against toxin A were not significantly associated with health care—associated C. This result is supported by a study of C.

Bacterial factors also affected outcomes in our study. We found that the NAP1 strain was an independent risk factor for health care—associated C. The NAP1 strain is postulated to be more virulent than others because of a deletion in the tcdC gene leading to increased toxin A and B production. Two studies have shown that colonization with nontoxigenic or toxigenic C. The incidence of health care—associated C.

As compared with previous studies, our study showed a higher incidence of health care—associated C. The differences between these two studies and ours can be explained by several factors. The NAP1 strain may be more likely than other strains to cause symptomatic disease. Also, the incidence of health care—associated C. Since we did not perform stool-specimen culture for asymptomatic patients at 60 days after discharge, we may have underestimated the incidence of health care—associated C.

Finally, admission criteria and case severity may have differed substantially between our study and the prior studies. A possible explanation is that both toxigenic and nontoxigenic strains colonize patients. Many of the toxigenic strains do not cause C.

Therefore, for a given C. Our study has several limitations. The patients with and those without data included in the analysis differed significantly in age; however, the difference 1.

The absence of clinically significant differences in baseline characteristics between participants and nonparticipants suggests that other confounding factors were also distributed evenly between the two groups, and no major bias was introduced. Second, we did not perform cultures of environmental samples or skin samples from the hands of personnel — two potential sources of health care—associated C.

Finally, our findings are limited to hospitalized patients and may not be applicable to patients with community-associated C. In conclusion, our study shows differential effects of age, medication use, and host immunity and pathogen variables on health care—associated C. The findings add to the understanding of C.

Supported by the Consortium de Recherche sur le Clostridium difficile ; the consortium consists of the following partners: Loo reports receiving consulting fees from Merck; Dr. Turgeon, receiving lecture fees from Merck; Dr.

Toye, receiving lecture fees from Pfizer Canada and owning stock in Spartan Biosciences; Dr. Oughton, receiving consulting fees from Cubist Pharmaceuticals; and Dr.

Dascal, receiving grant support from and owning stock in Cepheid and receiving grant support from Genome Canada. Disclosure forms provided by the authors are available with the full text of this article at NEJM. We thank all the patients who agreed to participate in the study; all the research assistants and technologists at the participating institutions for performing patient enrollment, data collection, and specimen collection and processing; Dr.

Marcel Behr for reviewing a draft of the manuscript; Dr. Ken Dewar and the McGill University Genome Quebec Innovation Centre for performing DNA sequencing; Mr. Ian Schiller and Ms. Sarah Vahey for assisting with data analysis; Ms.

From McGill University Health Centre V. Address reprint requests to Dr. Loo at the Department of Microbiology, McGill University Health Centre, Pine Ave. Barbut FCorthier GCharpak Yet al. Prevalence and pathogenicity of Clostridium difficile in hospitalized patients. Arch Intern Med ; Johnson SGerding DN. Clin Infect Dis ; Infect Control Hosp Epidemiol ; Loo VGPoirier LMiller Met al.

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Clostridium difficile Infection and Colonization. The New England Journal of Medicine. The narration and closed captions in this video are in English.

Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Background Clostridium difficile infection is the leading cause of health care—associated diarrhea, and the bacterium can also be carried asymptomatically. Methods We conducted a month prospective study in six Canadian hospitals in Quebec and Ontario.

Results A total of patients were included in the study; 2. Conclusions In this study, health care—associated C. Media in This Article Figure 1 Enrollment and Follow-up of the Study Patients. Figure 2 Times to Health Care—Associated Clostridium difficile Infection and Colonization during Hospitalization. Article Activity articles have cited this article. Methods Participating Hospitals Six Canadian, university-affiliated hospitals participated in the study: Study Population and Recruitment From March 6,to June 25,all consecutive patients 18 years of age or older admitted on selected units were asked to participate in the study.

Clinical Data Data on demographic information, known risk factors, and potential confounding factors were collected. Clinical Samples Rectal swabs or stool samples for toxigenic C. Laboratory Assays Toxigenic C. Statistical Analysis Epidemiologic and molecular data were collected and interpreted independently.

Results Study Units Each hospital had between 1 and 4 study units, for a total of 14 units: Study Patients A total of 12, patients were approached about participation, of whom were not eligible. Incidence and Outcomes Of the patients who could be evaluated, 4. Risk Factors for Health Care—Associated C. Discussion Health care—associated C. No other potential conflict of interest relevant to this article was reported.

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