Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Efficacy of Continuous vs. Intermittent Administration of Cefepime in Adult ICU Patients with Gram‐Negative Bacilli Bacteremia: A Randomized Double‐Blind Clinical Study

Carlos Arturo Álvarez-Moreno
* ORCID logo ,
Laura Cristina Nocua-Báez
,
Guillermo Ortiz
,
Juan Carlos Torres
,
Gabriel Montenegro
,
Williams Cervera
,
Alonso Gómez
,
Luis Fernando Zuluaga
Version 1 : Received: 23 December 2023 / Approved: 25 December 2023 / Online: 3 January 2024 (10:05:50 CET)

A peer-reviewed article of this Preprint also exists.

Álvarez-Moreno, C.A.; Nocua-Báez, L.C.; Ortiz, G.; Torres, J.C.; Montenegro, G.; Cervera, W.; Zuluaga, L.F.; Gómez, A. Efficacy of Continuous vs. Intermittent Administration of Cefepime in Adult ICU Patients with Gram-Negative Bacilli Bacteremia: A Randomized Double-Blind Clinical Study. Antibiotics 2024, 13, 229, doi:10.3390/antibiotics13030229. Álvarez-Moreno, C.A.; Nocua-Báez, L.C.; Ortiz, G.; Torres, J.C.; Montenegro, G.; Cervera, W.; Zuluaga, L.F.; Gómez, A. Efficacy of Continuous vs. Intermittent Administration of Cefepime in Adult ICU Patients with Gram-Negative Bacilli Bacteremia: A Randomized Double-Blind Clinical Study. Antibiotics 2024, 13, 229, doi:10.3390/antibiotics13030229.

Abstract

Introduction: The objective of this study was: compare the continuous infusion of cefepime with the intermittent infusion in patients with sepsis caused by Gram negative bacilli (GNB). Methods: Randomized 1:1 multicenter double-blinded placebo-controlled study with allocation concealment. Multicenter study in Intensive Care Units of Colombia. Patients with sepsis, severe sepsis or septic shock and GNB suspected bacteraemia. Cefepime was administered for 7 to 14 days over 30 m intermittently every 8 h over 24 h plus continuous saline solution (0.9%) (G1) or 3 g administered continuously plus saline solution every 8 h (0.9%) (G2). Percentage of clinical response at 3, 7, 14 days, relapse at 28 days and mortality at discharge were measured. Results: The recruitment was stopped by suggestion of the Institutional Review Board (IRB), following an FDA alert about cefepime. Thirty-two patients were randomized, 25 received the intervention and GNB bacteremia was confirmed in 16 (9 G1 and 7 G 2). Favourable clinical response in days 3,7,14 was 88.8%, 88.8%, 77.8 % (G 1) and was similar for G 2 (85.7%). There were not relapses and deaths in G2 while in G1 one relapse and 2 deaths were observed. Conclusions: The results of this study support the use of cefepime for the treatment of Gram-negative infections in critically ill patients but we could not demonstrate differences between continuous or intermittent administration, because of the small sample size, given the early suspension of the study.

Keywords

bacteraemia; cefepime; sepsis; intravenous infusions

Subject

Medicine and Pharmacology, Pharmacy

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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