Randomized, comparative study of oral ofloxacin versus intravenous cefotaxime in spontaneous bacterial peritonitis

Gastroenterology. 1996 Oct;111(4):1011-7. doi: 10.1016/s0016-5085(96)70069-0.


Background & aims: Treatment of spontaneous bacterial peritonitis currently involves intravenous antibiotic administration. To test the possibility of treating spontaneous bacterial peritonitis with oral antibiotics, oral ofloxacin was compared with intravenous cefotaxime in this infection.

Methods: One hundred twenty-three cirrhotics with uncomplicated spontaneous bacterial peritonitis (no septic shock, grade II-IV hepatic encephalopathy, serum creatinine level of > 3 mg/dL, and gastrointestinal hemorrhage or ileus) were randomly given oral ofloxacin (64 patients) or intravenous cefotaxime (59 patients).

Results: Infection resolution rate was 84% in the ofloxacin group and 85% in the cefotaxime group. Peak serum levels and trough serum and ascitic fluid levels of ofloxacin and cefotaxime measured on days 3 (23 patients) and 6 (11 patients) of therapy were greater than the minimal inhibitory concentration of isolated organisms. Hospital survival rate was 81% in each group of patients. Blood urea nitrogen and hepatic encephalopathy at diagnosis were associated with prognosis. None of the 36 nonazotemic patients with community-acquired spontaneous bacterial peritonitis and without hepatic encephalopathy developed complications during hospitalization, and all were alive at time of discharge.

Conclusions: Oral ofloxacin is as effective as intravenous cefotaxime in uncomplicated spontaneous bacterial peritonitis. Nonazotemic cirrhotic patients with uncomplicated community-acquired spontaneous bacterial peritonitis and without hepatic encephalopathy have an excellent prognosis and may be treated with oral ofloxacin without requiring hospitalization.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Infective Agents / administration & dosage*
  • Bacterial Infections / complications
  • Bacterial Infections / drug therapy*
  • Bacterial Infections / mortality
  • Cefotaxime / administration & dosage*
  • Cefotaxime / pharmacokinetics
  • Cephalosporins / administration & dosage*
  • Female
  • Humans
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Ofloxacin / administration & dosage*
  • Ofloxacin / pharmacokinetics
  • Peritonitis / complications
  • Peritonitis / drug therapy*
  • Peritonitis / mortality


  • Anti-Infective Agents
  • Cephalosporins
  • Ofloxacin
  • Cefotaxime