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We made an epidemiological case-control study to examine risk factors for the development of diarrhea in the intensive care unit (ICU) of a public hospital in Santo André, SP, from January to October 2002. Forty-nine patients with diarrhea (cases) and 49 patients without diarrhea (controls), matched for age and gender, were included in the study. A stool culture and enzyme immunoassays for Clostridium difficile toxins A and B were performed on fecal specimens from diarrhea patients. Fourteen of them presented positive cultures for Pseudomonas aeruginosa and 22 patients presented positive ELISA for Clostridium diffícile. Nosocomial diarrhea was associated with several factors, including use of antibiotics (P=0.001), use of ceftriaxone (P=0.001), presence of infection (P=0.010) and length of hospital stay (P=0.0001).