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PMID: 1734249 Published · ppublish English Clinical Trial Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

A controlled trial in intensive care units of selective decontamination of the digestive tract with nonabsorbable antibiotics. The French Study Group on Selective Decontamination of the Digestive Tract.

The New England journal of medicine ·Vol. 326 ·No. 9 ·1992-02-27 ·Pages 594-9

Gastinne H, Wolff M, Delatour F, Faurisson F, Chevret S

Abstract

Selective decontamination of the digestive tract with topical nonabsorbable antibiotics has been reported to prevent nosocomial infections in patients receiving mechanical ventilation, and the procedure is used widely in Europe. However, it is unclear whether selective decontamination improves survival. We conducted a randomized, double-blind multicenter study in which 445 patients receiving mechanical ventilation in 15 intensive care units were given either prophylactic nonabsorbable antibiotics (n = 220) or a placebo (n = 225). Topical antibiotics (tobramycin, colistin sulfate, and amphotericin B) or a placebo was administered through a nasogastric tube and applied to the oropharynx throughout the period of ventilation. The main end points were the mortality rate in the intensive care unit and within 60 days of randomization. A total of 142 patients died in the intensive care unit; 75 (34 percent) in the treatment group and 67 (30 percent) in the placebo group (P = 0.37). Mortality within 60 days of randomization was similar in the two groups (P = 0.40), even after adjustment for factors that were either unbalanced or individually predictive of survival in the two groups (P = 0.70). Pneumonia developed in 59 patients (13 percent) in the intensive care unit within 30 days of enrollment in the study (33 in the placebo group and 26 in the treatment group, P = 0.42). Pneumonia acquired in the intensive care unit and due to gram-negative bacilli was less frequent (P = 0.01) in the treatment group than in the placebo group. The total charges for antibiotics were 2.2 times higher in the treatment group. Selective decontamination of the digestive tract does not improve survival among patients receiving mechanical ventilation in the intensive care unit, although it substantially increases the cost of their care.

MeSH Terms
Administration, Topical Amphotericin B/administration & dosage Anti-Bacterial Agents/administration & dosage Colistin/administration & dosage Critical Care/economics,methods Cross Infection/prevention & control Digestive System/microbiology Double-Blind Method Female Gram-Negative Bacterial Infections/prevention & control Humans Intensive Care Units Male Middle Aged Multiple Organ Failure Pneumonia/prevention & control Respiration, Artificial Survival Rate Time Factors Tobramycin/administration & dosage
Chemicals
Anti-Bacterial Agents Amphotericin B Tobramycin Colistin
Authors & Affiliations
5 authors, click to expand affiliations / ORCID
Gastinne H
Service de Réanimation, Hôpital Universitaire Dupuytren, Limoges, France.
Wolff M
Delatour F
Faurisson F
Chevret S
Article Info
Journal
The New England journal of medicine
Abbr.
N Engl J Med
ISSN
0028-4793
Published
1992-02-27
Pages
594-9
Language
English
Region
United States
NLM ID
0255562
Subset
IM
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