Document Detail


Early antibiotic treatment for severe acute necrotizing pancreatitis: a randomized, double-blind, placebo-controlled study.
MedLine Citation:
PMID:  17457158     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
E Patchen Dellinger; Jose M Tellado; Norberto E Soto; Stanley W Ashley; Philip S Barie; Thierry Dugernier; Clement W Imrie; Colin D Johnson; Hanns-Peter Knaebel; Pierre-Francois Laterre; Enrique Maravi-Poma; Jorge J Olsina Kissler; Miguel Sanchez-Garcia; Stefan Utzolino
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of surgery     Volume:  245     ISSN:  0003-4932     ISO Abbreviation:  Ann. Surg.     Publication Date:  2007 May 
Date Detail:
Created Date:  2007-04-25     Completed Date:  2007-06-12     Revised Date:  2014-07-29    
Medline Journal Info:
Nlm Unique ID:  0372354     Medline TA:  Ann Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  674-83     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Aged, 80 and over
Anti-Bacterial Agents / administration & dosage*
Bacterial Infections / etiology,  prevention & control*
Cohort Studies
Double-Blind Method
Drug Administration Schedule
Female
Humans
Infusions, Intravenous
Male
Middle Aged
Pancreatitis, Acute Necrotizing / complications,  drug therapy*
Thienamycins / administration & dosage*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Thienamycins; 96036-03-2/meropenem
Comments/Corrections
Comment In:
Ann Surg. 2007 May;245(5):684-5   [PMID:  17457159 ]
Ann Surg. 2008 Feb;247(2):393-4; author reply 394-5   [PMID:  18216553 ]
Curr Gastroenterol Rep. 2007 Apr;9(2):97-8   [PMID:  17465081 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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