Clinical trial NCT01951781: Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns
Official title: Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nosocomial Infection
Keywords: marker CD64
blood sample
nosocomial infection
preterm newborn
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 153
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: proportion of negatives (healthy patient) which are correctly identified as such
timeFrame: day 1
Secondary outcomes:
measure: proportion of positives (sikness)which are correctly defined as such
timeFrame: day 1
measure: negative predictive CD64 value
timeFrame: day 1
measure: positive predictiveCD64 value
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University hospital
Study officials:
affiliation: Montpellier hospital
name: Gilles CAMBONIE, Professor
role: PRINCIPAL_INVESTIGATOR
References: