title: Prophylactic antibiotic treatment in patients with predicted severe acute pancreatitis: a placebo-controlled, double-blind trial.
abstract: OBJECTIVE
  Antibiotic prophylaxis in necrotizing pancreatitis remains controversial. Until now, there have been no double-blind studies dealing with this topic.
  
  
  METHODS
  A total sample size of 200 patients was calculated to demonstrate with a power of 90% that antibiotic prophylaxis reduces the proportion of patients with infected pancreatic necrosis from 40% placebo (PLA) to 20% ciprofloxacin/metronidazole (CIP/MET). One hundred fourteen patients with acute pancreatitis in combination with a serum C-reactive protein exceeding 150 mg/L and/or necrosis on contrast-enhanced CT scan were enrolled and received either intravenous CIP (2 x 400 mg/day) + MET (2 x 500 mg/day) or PLA. Study medication was discontinued and switched to open antibiotic treatment when infectious complications, multiple organ failure sepsis, or systemic inflammatory response syndrome (SIRS) occurred. After half of the planned sample size was recruited, an adaptive interim analysis was performed, and recruitment was stopped.
  
  
  RESULTS
  Fifty-eight patients received CIP/MET and 56 patients PLA. Twenty-eight percent in the CIP/MET group required open antibiotic treatment vs. 46% with PLA. Twelve percent of the CIP/MET group developed infected pancreatic necrosis compared with 9% of the PLA group (P = 0.585). Mortality was 5% in the CIP/MET and 7% in the PLA group. In 76 patients with pancreatic necrosis on contrast-enhanced CT scan, no differences in the rate of infected pancreatic necrosis, systemic complications, or mortality were observed.
  
  
  CONCLUSIONS
  This study detected no benefit of antibiotic prophylaxis with respect to the risk of developing infected pancreatic necrosis.
authors.affiliation: Department of Abdominal and Transplantational Surgery, University of Ulm, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Isenmann
authors.forename: Michael
authors.initials: M
authors.lastname: Rünzi
authors.forename: Martina
authors.initials: M
authors.lastname: Kron
authors.forename: Stefan
authors.initials: S
authors.lastname: Kahl
authors.forename: Dietmar
authors.initials: D
authors.lastname: Kraus
authors.forename: Norbert
authors.initials: N
authors.lastname: Jung
authors.forename: Ludwig
authors.initials: L
authors.lastname: Maier
authors.forename: Peter
authors.initials: P
authors.lastname: Malfertheiner
authors.forename: Harald
authors.initials: H
authors.lastname: Goebell
authors.forename: Hans G
authors.initials: HG
authors.lastname: Beger
mesh_terms: D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002939:Ciprofloxacin / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D016905:Gram-Negative Bacterial Infections / Q000188:drug therapy / Q000517:prevention & control; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D019283:Pancreatitis, Acute Necrotizing / Q000188:drug therapy* / Q000517:prevention & control*; D010919:Placebos
chemical_list: D000890:Anti-Infective Agents; D010919:Placebos; D008795:Metronidazole; D002939:Ciprofloxacin