Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns (NEOCD64)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01951781|
Recruitment Status : Unknown
Verified September 2013 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : September 27, 2013
Last Update Posted : January 9, 2015
Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and biological markers in the infection initial phase .The aim of this study is to determine the performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial infection (NI) in preterm newborns.
- Monocentric prospective study including preterm newborn infants (<37 weeks of gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal intensice care unit (Neonatal intensive care unit of Montpellier, France).
- Patients will be enrolled in the study after informed consents. Rapid and automated CD64 measurment will be realized during the conventional blood sample including C-Reactive Protein (CRP), Procalcitonin (PCT) and blood culture.
Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded the result of CD64. Patients will be then classed in three groups using CDC criteria (center for disease control) : 1-no infection, 2-infection, 3-possible infection during the multidisciplinary staff. Specificity, sensitivity, negative and positive value of CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared.
153 patients are needed in the study enrolled during a period of 12 months.
PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial infections in neonates.CD64 allow to integrate in a decision algorithm with the determination of the best cut-off value to faster processing nosocomial infections and could help to reduce unnecessary antibioc therapy. A rapid technique for determination of CD64 should be readily available in our unit.
|Condition or disease||Intervention/treatment||Phase|
|Nosocomial Infection||Other: blood sample||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||November 2015|
NEOCD64 : dosage of CD64 blood marker in preterm newborn who are suspected of nosocomial infection (blood sample)
Other: blood sample
blood sample in newborn preterms suspected of nosocomial infection (neoCD64 arm)
When late-onset sepsis is suspected, blood samples are obtained from peripheral veins for a complete blood count, measurement of CRP and PCT concentration and one bacterial culture acording to the current recommendation of the CDC. CD64 concentration measurement require 0.2 ml aditionnal blood.
- proportion of negatives (healthy patient) which are correctly identified as such [ Time Frame: day 1 ]
- proportion of positives (sikness)which are correctly defined as such [ Time Frame: day 1 ]sensibility of CD64 value
- negative predictive CD64 value [ Time Frame: day 1 ]
- positive predictiveCD64 value [ Time Frame: day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951781
|Contact: Gilles CAMBONIE, Professoremail@example.com|
|Contact: Sabine DURAND, firstname.lastname@example.org|
|Montpellier University hospital||Recruiting|
|Montpellier, France, 34295|
|Principal Investigator: Gilles Cambonie, Professor|
|Sub-Investigator: Sabine Durand, Doctor|
|Principal Investigator:||Gilles CAMBONIE, Professor||Montpellier hospital|