Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.
|ClinicalTrials.gov Identifier: NCT01450358|
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : June 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Bacteremia Fungemia||Other: Antibiotic regimen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Active Comparator: Pathogen detection by Multiplex PCR
Blood samples for cultures and Multiplex PCR will be collected before start the antibiotic therapy in patients with sepsis. Multiplex PCR will be immediately undertaken and its results will be reported to prompt medical researcher (6-12 hours).The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR.
Other: Antibiotic regimen
The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR (6-12 h).
No Intervention: Pathogen detection by blood culture
Blood samples for cultures and Multiplex PCR will be collected before start the antibiotic therapy in patients with sepsis. The results of multiplex PCR will be not informed to the medical researcher, being focused care as a result of blood culture (at least after 72 hours).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450358
|Instituto do Coracao|
|Sao Paulo, São Paulo, Brazil, 05403000|
|Principal Investigator:||Tania MV Strabelli, PhD||Instituto do Coracao|