Back to resultsEvaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.
Primary Purpose
Sepsis, Bacteremia, Fungemia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Antibiotic regimen
Sponsored by
About this trial
This is an interventional diagnostic trial for Sepsis focused on measuring Sepsis, Real time PCR, Blood culture, Bacteremia diagnosis, Fungemia diagnosis
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
Sites / Locations
- Instituto do Coracao
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Pathogen detection by Multiplex PCR
Pathogen detection by blood culture
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01450358
First Posted
October 10, 2011
Last Updated
June 7, 2016
Sponsor
Instituto do Coracao
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01450358
Brief Title
Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Coracao
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Bacteremia, Fungemia
Keywords
Sepsis, Real time PCR, Blood culture, Bacteremia diagnosis, Fungemia diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pathogen detection by Multiplex PCR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pathogen detection by blood culture
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Antibiotic regimen
Intervention Description
The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR (6-12 h).
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania MV Strabelli, PhD
Organizational Affiliation
Instituto do Coracao
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Coracao
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
31367384
Citation
Rodrigues C, Siciliano RF, Filho HC, Charbel CE, de Carvalho Sarahyba da Silva L, Baiardo Redaelli M, de Paula Rosa Passetti AP, Franco MRG, Rossi F, Zeigler R, De Backer D, Franco RA, de Almeida JP, Rizk SI, Fukushima JT, Landoni G, Uip DE, Hajjar LA, Strabelli TMV. The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial. J Intensive Care. 2019 Jul 22;7:37. doi: 10.1186/s40560-019-0391-3. eCollection 2019.
Results Reference
derived
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Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.
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