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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Instituto do Coracao
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tania Mara Varejão Strabelli
PhD, Director of Infection Control Unit
Instituto do Coracao
Eligibility Criteria
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
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