MedTrace Logo

Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns

NCT01951781 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2015-01-09

No results posted yet for this study

Summary

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.

METHODS :

* 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.

Conditions

  • Nosocomial Infection

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Gilles CAMBONIE, Professor · Montpellier hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-06-30
Completion
2015-11-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01951781 on ClinicalTrials.gov