March 13, 2014
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Model may predict patients at risk for CDI recurrence

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A prediction model using clinical factors may be a useful tool to determine patients at risk for Clostridium difficile infection recurrence, researchers from Boston University have found.

“The proposed risk assessment model can be used when the patient makes initial contact with a health care worker to estimate the risk of recurrent infection within the 25 days of stopping CDI treatment,” the researchers wrote in Clinical Infectious Diseases. “In addition, inclusion of treatment in the model provides a guide to risk of recurrence when choosing vancomycin or fidaxomicin.”

The researchers used data from two phase 3 trials comparing fidaxomicin (Dificid, Cubist Pharmaceuticals) and vancomycin in adults with CDI. Seven classes of risks factors were evaluated as potential prediction factors for recurrence and each risk factor underwent univariate logistic regressions. The prediction model included the following factors: age, number of unformed bowel movements during the previous 24 hours, serum creatinine at baseline and prior episodes of CDI, as well at treatment.

The model was evaluated in 922 patients. In the first trial, 15.4% of the patients on fidaxomicin and 25.3% of the patients on vancomycin experienced recurrence, and in the second trial, 12.7% of patients on fidaxomicin and 26.9% of patients on vancomycin experienced recurrence. The model was applied to two independent samples from both studies, and the accuracy of the model was similar in both studies individually and both studies combined.

“Recurrence of CDI is associated with substantial morbidity and mortality and increased medical costs,” the researchers wrote. “It represents an unresolved area of concern in the management of CDI.”

Disclosure: Some researchers are employees of Cubist Pharmaceuticals.