title: Early antibiotic treatment for severe acute necrotizing pancreatitis: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  In patients with severe, necrotizing pancreatitis, it is common to administer early, broad-spectrum antibiotics, often a carbapenem, in the hope of reducing the incidence of pancreatic and peripancreatic infections, although the benefits of doing so have not been proved.
  
  
  METHODS
  A multicenter, prospective, double-blind, placebo-controlled randomized study set in 32 centers within North America and Europe.
  
  
  METHODS
  One hundred patients with clinically severe, confirmed necrotizing pancreatitis: 50 received meropenem and 50 received placebo.
  
  
  METHODS
  Meropenem (1 g intravenously every 8 hours) or placebo within 5 days of the onset of symptoms for 7 to 21 days.
  
  
  METHODS
  Primary endpoint: development of pancreatic or peripancreatic infection within 42 days following randomization. Other endpoints: time between onset of pancreatitis and the development of pancreatic or peripancreatic infection; all-cause mortality; requirement for surgical intervention; development of nonpancreatic infections within 42 days following randomization.
  
  
  RESULTS
  Pancreatic or peripancreatic infections developed in 18% (9 of 50) of patients in the meropenem group compared with 12% (6 of 50) in the placebo group (P = 0.401). Overall mortality rate was 20% (10 of 50) in the meropenem group and 18% (9 of 50) in the placebo group (P = 0.799). Surgical intervention was required in 26% (13 of 50) and 20% (10 of 50) of the meropenem and placebo groups, respectively (P = 0.476).
  
  
  CONCLUSIONS
  This study demonstrated no statistically significant difference between the treatment groups for pancreatic or peripancreatic infection, mortality, or requirement for surgical intervention, and did not support early prophylactic antimicrobial use in patients with severe acute necrotizing pancreatitis.
authors: Division of General Surgery, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195, USA. patch@u.washington.edu
authors: E Patchen
authors: EP
authors: Dellinger
authors: Jose M
authors: JM
authors: Tellado
authors: Norberto E
authors: NE
authors: Soto
authors: Stanley W
authors: SW
authors: Ashley
authors: Philip S
authors: PS
authors: Barie
authors: Thierry
authors: T
authors: Dugernier
authors: Clement W
authors: CW
authors: Imrie
authors: Colin D
authors: CD
authors: Johnson
authors: Hanns-Peter
authors: HP
authors: Knaebel
authors: Pierre-Francois
authors: PF
authors: Laterre
authors: Enrique
authors: E
authors: Maravi-Poma
authors: Jorge J Olsina
authors: JJ
authors: Kissler
authors: Miguel
authors: M
authors: Sanchez-Garcia
authors: Stefan
authors: S
authors: Utzolino
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000209:etiology / Q000517:prevention & control*; D015331:Cohort Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D000077731:Meropenem; D008875:Middle Aged; D019283:Pancreatitis, Acute Necrotizing / Q000150:complications / Q000188:drug therapy*; D013845:Thienamycins / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D013845:Thienamycins; D000077731:Meropenem