Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns (NEOCD64)

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

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.

Study Overview

• Status: Unknown
• Conditions: Nosocomial Infection
• Intervention / Treatment: Other: blood sample

• Study Type: Interventional
• Enrollment (Anticipated): 153
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilles CAMBONIE, Professor; Phone Number: 33467336609; Email: g-cambonie@chu-montpellier.fr
• Study Contact Backup: Name: Sabine DURAND, doctor; Phone Number: 33467336609; Email: s-durand@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Montpellier University Hospital
    • Principal Investigator: Gilles Cambonie, Professor
    • Sub-Investigator: Sabine Durand, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: NEOCD64; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Gilles CAMBONIE, Professor, Montpellier Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ANTICIPATED): November 1, 2015

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (ESTIMATE): September 27, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: blood sample; nosocomial infection; preterm newborn; marker CD64
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: 9117