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OpenTrials
Completed

NCT Number: NCT01450358

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto do Coracao

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic regimen

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Instituto do Coracao

Other Gov

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 12, 2011
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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