CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01378169
NCT01378169N/ACompleted

Early Detection and Diagnostic Performance of Bio-markers During Bacterial Sepsis: Multicentre Cohort Study in Intensive Care

Fondation Hôpital Saint-Joseph·observational·Posted Jun 22, 2011·Updated Oct 17, 2017

In Brief

An observational study for SIRS and 3 related conditions. Completed, enrolled 300 participants across 1 site.

Detailed Summary

Aim of the study : The primary aim of the investigators study is to highlight the presence of biomarkers (biological indicators of the presence of inflammation or infection) of infectious processes during the systemic inflammatory response (SIRS) allowing, first to discriminate non-infectious inflammation from infectious processes and secondary to determine the microbial pathogen responsive of the infection. For this purpose the investigators will conduct a combinatorial approach of several blood markers including usual markers of inflammation and other blood and cells markers. Expression of small pieces of RNA (miRNA) known to inhibit determined gene expression, will also be analysed in monocytes (a specific group of white blood cells involved in the fist line of defences against microbes. Study design : For this purpose the investigators will include 300 patients admitted to the intensive care unit with suspicion of infection. Serial blood sample will be take for biological parameters analysis. Efficiency of each single parameters and of different combinations of different markers to determine the presence or absence of infection responsive of clinical inflammation will be studied.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2011
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.0 years ago