Norfloxacin primary prophylaxis of bacterial infections in cirrhotic patients with ascites: a double-blind randomized trial

Autor: Pierre Blanc, Dominique Roulot, Jean-Pierre Vinel, Francoise Delisle, Xavier Amiot, Antoine Flahault, Jean Philippe Richardet, Jean-Didier Grangé, Daniel Fischer, Gilles Pelletier, E. A. Pariente, Olivier Ink, Jacques Denis
Jazyk: angličtina
Rok vydání: 1998
Předmět:
Liver Cirrhosis
Liver Cirrhosis/*complications/mortality
Male
Feces/microbiology
Cirrhosis
Gastroenterology
France/epidemiology
law.invention
Feces
Randomized controlled trial
Anti-Infective Agents
law
Ascites
Antibacterial agent
Incidence
Middle Aged
Survival Rate
Chemoprophylaxis
Female
France
medicine.symptom
medicine.drug
Adult
medicine.medical_specialty
Peritonitis
Placebo
Double blind
Norfloxacin/adverse effects/*therapeutic use
Spontaneous bacterial peritonitis
Double-Blind Method
Internal medicine
Anti-Infective Agents/adverse effects/*therapeutic use
medicine
Humans
Norfloxacin
Aged
Hepatology
business.industry
Ascites/complications/*drug therapy/mortality
bacterial infections and mycoses
medicine.disease
Surgery
Bacteremia
Gram-Negative Bacterial Infections/complications/epidemiology/*prevention & control
Patient Compliance
business
Gram-Negative Bacterial Infections
Zdroj: Journal of Hepatology, Vol. 29, No 3 (1998) pp. 430-6
ISSN: 0168-8278
Popis: Norfloxacin is useful to prevent infections in hospitalized cirrhotic patients with low ascitic fluid protein concentrations. It is also effective in preventing the recurrence of spontaneous bacterial peritonitis. The aim of our study was to determine the efficacy of norfloxacin in the primary prophylaxis of gram-negative bacilli infections in cirrhotic patients with low ascitic fluid protein levels (15 g/l).One hundred and seven patients were randomized to receive norfloxacin (400 mg/day; n=53) or placebo (n=54) for 6 months. The patients had no history of infection since cirrhosis diagnosis and no active infection.The probability of gram-negative infection was significantly lower among patients treated with norfloxacin than among those treated with placebo. Six gram-negative bacilli infections occurred in the placebo group and none in the treatment group. Severe infections (spontaneous bacterial peritonitis, neutrocytic ascites and bacteremia) developed in nine patients in the placebo group (17%) and in one patient in the norfloxacin group (2%; p0.03). There was no between-group difference in the overall rate of infection or in survival. In ten patients from the norfloxacin group, gram-negative bacilli not present in baseline stool cultures were transiently isolated in follow-up cultures.These data show that primary prophylaxis with norfloxacin for 6 months is effective in the prevention of infections caused by gram-negative bacilli in cirrhotic patients with low ascitic fluid total protein levels.
Databáze: OpenAIRE