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Early antibiotic treatment for severe acute necrotizing pancreatitis - A randomized, double-blind, placebo-controlled study

Dellinger, E.P., Tellado, J.M., Soto, N.E., Ashley, S.W., Barie, P.S., Dugernier, T., Imrie, C.W., Johnson, C.D., Knaebel, H.P., Laterre, P.F., Maravi-Poma, E., Kissler, J.J.O., Sanchez-Garcia, M. and Utzolino, S. (2007) Early antibiotic treatment for severe acute necrotizing pancreatitis - A randomized, double-blind, placebo-controlled study Annals of Surgery, 245, (5), pp. 674-683.

Record type: Article


Background & Aims: 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. Participants: One hundred patients with clinically severe, confirmed necrotizing pancreatitis: 50 received meropenem and 50 received placebo. Interventions: Meropenem (1 g intravenously every 8 hours) or placebo within 5 days of the onset of symptoms for 7 to 21 days. Main Outcome Measures: 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

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Published date: 2007
Keywords: women, prophylactic antibiotics, pancreatitis, development, infection, management, ct, europe, necrosis, septic complications, debridement, imipenem, multicenter, controlled clinical-trial, time, patient, mortality


Local EPrints ID: 62721
ISSN: 0003-4932
PURE UUID: 3bfd1fdd-ab92-4189-8a18-c021eb092706

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Date deposited: 04 Sep 2008
Last modified: 17 Jul 2017 14:20

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Author: E.P. Dellinger
Author: J.M. Tellado
Author: N.E. Soto
Author: S.W. Ashley
Author: P.S. Barie
Author: T. Dugernier
Author: C.W. Imrie
Author: C.D. Johnson
Author: H.P. Knaebel
Author: P.F. Laterre
Author: E. Maravi-Poma
Author: J.J.O. Kissler
Author: M. Sanchez-Garcia
Author: S. Utzolino

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