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Evaluation of antimicrobial use and time of treatment of nosocomial sepsis comparing polymerase chain reaction (PCR) in real time multiplex to the conventional blood culture for etiologic agents identification: randomized clinical trial

Grant number: 11/09865-9
Support type:Regular Research Grants
Duration: September 01, 2011 - August 31, 2014
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Tânia Mara Varejão Strabelli
Grantee:Tânia Mara Varejão Strabelli
Home Institution: Instituto do Coração Professor Euryclides de Jesus Zerbini (INCOR). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
Assoc. researchers:Alberto José da Silva Duarte ; Cecilia Eugênia Charbel ; Cristhieni Rodrigues ; Flávia Rossi ; Helio Hehl Caiaffa Filho ; Luciane de Carvalho Sarahyba da Silva ; Maria Renata Gomes Franco ; Roberta Ferreira Mariano

Abstract

Sepsis is the main cause of death in intensive care units all over the world. Early identification of the etiologic agent is essential for the appropriate antimicrobial treatment. Until now, blood culture was the standard diagnostic test for detection of blood pathogens. Meanwhile there are some limitations like low sensitivity and delay in identifying the causative organism resulting in a greater possibility of error and increased use of empirical antimicrobials. These could result in selection of resistant microorganisms, greater toxicity, longer hospital stay and costs. Therefore, faster and more sensitivity laboratory tests are necessary to improve effective antimicrobial therapy of sepsis.The objective of this study is to evaluate the consumption and time of antimicrobial therapy in patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis. The percentage agreement between the two methods will also be evaluated as well as the clinical and laboratorial evolution, mortality, hospital length of stay and costs in the two groups.All patients 18 or more years old staying more than 48 hours in hospital with clinical suspicion of sepsis could be included in the study. Blood samples for cultures and PCR will be collected immediately prior to initiation of antibiotic therapy. Patients will be randomly selected into two groups. In Group I, the PCR results will be reported to the medical researcher (up to 12 hours), which will adjust the antimicrobial regimen. In Group II, the PCR results will not be informed, being focused care as a result of blood culture (at least after 72 hours). The initial empirical antimicrobial therapy will be the same in both groups, according to the standardization of the institution.It's estimated that this study contributes to the improvement in the treatment of nosocomial sepsis, with reduced use of empirical broad spectrum antimicrobial and shorter hospitalization. (AU)