Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns

Study Overview
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Brief Summary
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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.

Official Title
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Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns

Conditions
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Nosocomial Infection

Intervention / Treatment
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* Other: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm newborn (<37 weeks of gestationnal age ) undergoing symptoms of late-onset-sepsis written informed consent obtained from the parents Exclusion Criteria: patient undergoing antibiotic therapy patient undergoing surgery in the last seven days, patient with severe congenital malformation necrotizing enterocolitis parents unable to understand the purpose of the study no affiliation to social security

Ages Eligible for Study
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Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NEOCD64<br>NEOCD64 : dosage of CD64 blood marker in preterm newborn who are suspected of nosocomial infection (blood sample) | Other: blood sample<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of negatives (healthy patient) which are correctly identified as such |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of positives (sikness)which are correctly defined as such | sensibility of CD64 value | day 1 | 
| negative predictive CD64 value |  | day 1 | 
| positive predictiveCD64 value |  | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marker CD64, blood sample, nosocomial infection, preterm newborn