Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns (NEOCD64)
Primary Purpose
Nosocomial Infection
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Nosocomial Infection focused on measuring marker CD64, blood sample, nosocomial infection, preterm newborn
Eligibility Criteria
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
Sites / Locations
- Montpellier University hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NEOCD64
Arm Description
NEOCD64 : dosage of CD64 blood marker in preterm newborn who are suspected of nosocomial infection (blood sample)
Outcomes
Primary Outcome Measures
proportion of negatives (healthy patient) which are correctly identified as such
Secondary Outcome Measures
proportion of positives (sikness)which are correctly defined as such
sensibility of CD64 value
negative predictive CD64 value
positive predictiveCD64 value
Full Information
NCT ID
NCT01951781
First Posted
September 18, 2013
Last Updated
January 8, 2015
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01951781
Brief Title
Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns
Acronym
NEOCD64
Official Title
Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infection
Keywords
marker CD64, blood sample, nosocomial infection, preterm newborn
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
N/A
Enrollment
153 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NEOCD64
Arm Type
Other
Arm Description
NEOCD64 : dosage of CD64 blood marker in preterm newborn who are suspected of nosocomial infection (blood sample)
Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportion of negatives (healthy patient) which are correctly identified as such
Time Frame
day 1
Secondary Outcome Measure Information:
Title
proportion of positives (sikness)which are correctly defined as such
Description
sensibility of CD64 value
Time Frame
day 1
Title
negative predictive CD64 value
Time Frame
day 1
Title
positive predictiveCD64 value
Time Frame
day 1
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles CAMBONIE, Professor
Phone
33467336609
Email
g-cambonie@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine DURAND, doctor
Phone
33467336609
Email
s-durand@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles CAMBONIE, Professor
Organizational Affiliation
Montpellier hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Cambonie, Professor
First Name & Middle Initial & Last Name & Degree
Sabine Durand, Doctor
12. IPD Sharing Statement
Learn more about this trial
Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns
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