Early antibiotic treatment for severe acute necrotizing pancreatitis: a randomized, double-blind, placebo-controlled study.
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.
Dellinger
E Patchen
EP
Division of General Surgery, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195, USA. patch@u.washington.edu
Tellado
Jose M
JM
Soto
Norberto E
NE
Ashley
Stanley W
SW
Barie
Philip S
PS
Dugernier
Thierry
T
Imrie
Clement W
CW
Johnson
Colin D
CD
Knaebel
Hanns-Peter
HP
Laterre
Pierre-Francois
PF
Maravi-Poma
Enrique
E
Kissler
Jorge J Olsina
JJ
Sanchez-Garcia
Miguel
M
Utzolino
Stefan
S
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
D000900:Anti-Bacterial Agents; D013845:Thienamycins; D000077731:Meropenem