title: Primary prophylaxis with ciprofloxacin in cirrhotic patients with ascites: a randomized, double blind study.
abstract: INTRODUCTION AND AIM. There is scarce information about primary prophylaxis in cirrhotic patients. The aim was to assess the efficacy of ciprofloxacin for primary prophylaxis for bacterial infections in patients with cirrhosis of the liver and ascites. MATERIAL AND METHODS. A randomized, double-blind placebo-controlled clinical trial was conducted. Patients were randomized to receive oral ciprofloxacin 500 mg/day or placebo for one month. A basal evaluation and repeated assessments at 4, 6, 12, 18, and 24 weeks afterwards, or whenever a primary endpoint occurred were done.
  
  
  METHODS
  probability curves were constructed with the Kaplan-Meier method and compared by the log-rank test. RESULTS. 95 patients were randomized to ciprofloxacin group (n = 49; 51.6%) and placebo group (n = 46; 48.4%). Six-teen (32.6%) patients in the ciprofloxacin group developed bacterial infections and thirteen (28.2%) patients developed bacterial infections in the placebo group (p = NS). The probability to remain free of bacterial infections did not reach statistical significance (p = 0.38). Probability of survival at 24 weeks was 91% in placebo group and 98% in the ciprofloxacin group (p = 0.28). The absolute risk reduction was 5%, the relative risk reduction was 6% and the NNT was 20 patients. CONCLUSION. Primary prophylaxis with ciprofloxacin for one month in cirrhotic patients with ascites who do not have a currently accepted indication, did not show a preventive effect on the development of bacterial infections at one month follow-up. Moreover in women could increases the odds for UTI. The administration of ciprofloxacin seemed to decrease the risk of mortality.
authors.affiliation: Department of Endoscopy Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.
authors.forename: Félix
authors.initials: F
authors.lastname: Téllez-Ávila
authors.affiliation: Department of Infectious Diseases Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.
authors.forename: José
authors.initials: J
authors.lastname: Sifuentes-Osornio
authors.affiliation: Department of Gastroenterology Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.
authors.forename: Varenka
authors.initials: V
authors.lastname: Barbero-Becerra
authors.affiliation: Department of Gastroenterology Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.
authors.forename: Ada
authors.initials: A
authors.lastname: Franco-Guzmán
authors.affiliation: Department of Gastroenterology Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.
authors.forename: Roberto
authors.initials: R
authors.lastname: Ruiz-Cordero
authors.affiliation: Department of Gastroenterology Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.
authors.forename: Roberto
authors.initials: R
authors.lastname: Alfaro-Lara
authors.affiliation: Department of Gastroenterology Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.
authors.forename: Angeles
authors.initials: A
authors.lastname: Hernández-Ramírez
authors.affiliation: Department of Gastroenterology Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.
authors.forename: Florencia
authors.initials: F
authors.lastname: Vargas-Vorácková
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001201:Ascites / Q000150:complications*; D001424:Bacterial Infections / Q000150:complications / Q000517:prevention & control*; D002939:Ciprofloxacin / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010538:Peritonitis / Q000150:complications / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D002939:Ciprofloxacin