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

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.

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Fungemia; Bacteremia
• Intervention / Treatment: Other: Antibiotic regimen

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 05403000
      • Instituto do Coracao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	After fourteen days of antimicrobial treatment

Collaborators and Investigators

• Sponsor: Instituto do Coracao
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Tania MV Strabelli, PhD, Instituto do Coracao

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 10, 2011
• First Submitted That Met QC Criteria: October 10, 2011
• First Posted (Estimate): October 12, 2011

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Sepsis; Blood culture; Real time PCR; Bacteremia diagnosis; Fungemia diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Sepsis; Toxemia; Bacteremia; Fungemia; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: PCR multiplex