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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01450358
Other study ID # PCR multiplex
Secondary ID
Status Completed
Phase Phase 4
First received October 10, 2011
Last updated June 7, 2016
Start date January 2012
Est. completion date May 2016

Study information

Verified date June 2016
Source Instituto do Coracao
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Instituto do Coracao Sao Paulo São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Instituto do Coracao Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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