title: Prospective observational study comparing three different treatment regimes in patients with Clostridium difficile infection.
abstract: In a hospital-based, prospective cohort study, the effects of the three standard treatment regimens for mild Clostridium difficile infection (CDI), oral (p.o.) metronidazole at 500 mg three times/day, intravenous (i.v.) metronidazole at 500 mg three times/day, and oral (p.o.) vancomycin at 250 mg four times/day, were compared with respect to the risk of occurrence of complications, sequelae, and all-cause death within 30 days after the date of starting treatment. Differences in the incidence of these outcomes were tested by χ² or Fisher's exact tests. A Poisson regression model was performed to control for possible confounding effects of sex, age, and severity of comorbidity categorized according to the Charlson comorbidity index. The highest mortality was observed in the metronidazole i.v. group, with a mortality rate 38.1% (16/42) compared to mortality rates of 7.4% (9/121) in the metronidazole p.o. group and 9.5% (4/42) in the vancomycin p.o. group (P < 0.001). After adjustment for possible effects of sex, age (> 65 years), and severity of comorbidity, the relative risk of a 30-day fatal outcome for patients receiving metronidazole i.v. was 4.3 (95% confidence interval [CI] = 1.92 to 10; P < 0.0001) compared to patients treated with metronidazole p.o. and 4.0 (95% CI = 1.31 to 5.0; P < 0.015) compared to patients treated with vancomycin p.o. There were no significant differences in the risk of complications between the three treatment groups. This study generates the hypothesis that treatment with i.v. metronidazole is inferior to the oral alternatives metronidazole and vancomycin.
authors.affiliation: Department of Medicine, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: Judith M
authors.initials: JM
authors.lastname: Wenisch
authors.forename: Daniela
authors.initials: D
authors.lastname: Schmid
authors.forename: Hung-Wei
authors.initials: HW
authors.lastname: Kuo
authors.forename: Franz
authors.initials: F
authors.lastname: Allerberger
authors.forename: Verena
authors.initials: V
authors.lastname: Michl
authors.forename: Philip
authors.initials: P
authors.lastname: Tesik
authors.forename: Gerhard
authors.initials: G
authors.lastname: Tucek
authors.forename: Hermann
authors.initials: H
authors.lastname: Laferl
authors.forename: Christoph
authors.initials: C
authors.lastname: Wenisch
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D016360:Clostridioides difficile; D015331:Cohort Studies; D003627:Data Interpretation, Statistical; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D004761:Enterocolitis, Pseudomembranous / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D005243:Feces / Q000382:microbiology; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000627:therapeutic use*; D008875:Middle Aged; D016012:Poisson Distribution; D011446:Prospective Studies; D012306:Risk; D012737:Sex Factors; D016896:Treatment Outcome; D014640:Vancomycin / Q000008:administration & dosage* / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D014640:Vancomycin