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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Instituto do Coracao
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Tania Mara Varejão Strabelli, Instituto do Coracao
ClinicalTrials.gov Identifier:
NCT01450358
First received: October 10, 2011
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Sepsis
Bacteremia
Fungemia
Other: Antibiotic regimen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Instituto do Coracao:

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. [ Time Frame: After fourteen days of antimicrobial treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450358

Contacts
Contact: Cristhieni Rodrigues, MD 551126615000 ext 5358 cristhieni.rodrigues@incor.usp.br
Contact: Rogério Zeigler, MD 551126615000 ext 5349 rogerio.zeigler@incor.usp.br

Locations
Brazil
Instituto do Coracao Recruiting
Sao Paulo, São Paulo, Brazil, 05403000
Contact: Cristhieni Rodrigues, MD    551126615000 ext 5358    cristhieni@uol.com.br   
Contact: Rogério Zeigler, MD    551126615000 ext 5349    rogerio.zeigler@incor.usp.br   
Principal Investigator: Tania MV Strabelli, PhD         
Sponsors and Collaborators
Instituto do Coracao
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Tania MV Strabelli, PhD Instituto do Coracao
  More Information

No publications provided

Responsible Party: Tania Mara Varejão Strabelli, PhD, Director of Infection Control Unit, Instituto do Coracao
ClinicalTrials.gov Identifier: NCT01450358     History of Changes
Other Study ID Numbers: PCR multiplex
Study First Received: October 10, 2011
Last Updated: March 4, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Coracao:
Sepsis
Real time PCR
Blood culture
Bacteremia diagnosis
Fungemia diagnosis

Additional relevant MeSH terms:
Bacteremia
Sepsis
Toxemia
Fungemia
Bacterial Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Mycoses
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 21, 2014