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

NCT01450358 | Completed Phase 4

• 1 other identifier: PCR multiplex
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Bacteremia; Fungemia

Keywords

Sepsis; Real time PCR; Blood culture; Bacteremia diagnosis; Fungemia diagnosis

Outcome Measures

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.

  After fourteen days of antimicrobial treatment

Study Arms (2)

Pathogen detection by Multiplex PCR

ACTIVE COMPARATOR

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

Pathogen detection by blood culture

NO INTERVENTION

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).

Interventions

Antibiotic regimen OTHER

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

Pathogen detection by Multiplex PCR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient submitted to cardiovascular surgery in the last fifteen days
• Patient or responsible are not able to provide informed consent

Sponsors & Collaborators

• Instituto do Coracao: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto do Coracao

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31367384 DERIVED

MeSH Terms

Conditions

Sepsis; Bacteremia; Fungemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Invasive Fungal Infections; Mycoses

Study Officials

• Tania MV Strabelli, PhD

  Instituto do Coracao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Director of Infection Control Unit

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 12, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

BR (1)