Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.

Instituto do Coracao200 enrolled

Overview

The objective of this study is to evaluate the consumption 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.

Patients staying more than 48 hours in hospital with clinical suspicion of sepsis could be included in the study. Blood samples for cultures and multiplex 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 immediately reported to the medical researcher (6-12 hours), which will change the antimicrobial regimen (De-escalation). In Group II, the Multiplex 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

200

Conditions

Sepsis Bacteremia Fungemia

Interventions

Antibiotic regimenOTHER

The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR (6-12 h).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient 18 or more years old * Patient staying more than 48 hours in hospital * Patient with clinical suspicion of infection and presenting at leat two of the following criteria:temperature \> 38oC or \< 36oC, heart rate \> 90 beats/minute, respiratory rate \> 20 breaths/minute or PaCO2 \< 32 mmHg or leukocytosis \>12 000/μl or leukopenia \<4000/μl or normal white blood cell count with \>10% immature forms * Patient or responsible able to provide informed consent Exclusion Criteria: * Patient submitted to cardiovascular surgery in the last fifteen days * Patient or responsible are not able to provide informed consent

Locations (1)

Instituto do Coracao

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Evaluation of antimicrobial use in number of days comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis.

Time frame: After fourteen days of antimicrobial treatment

Data from ClinicalTrials.gov

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