Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns

Not Applicable

• Conditions: Nosocomial Infection
• Interventions: Other: blood sample

• Registration Number: NCT01951781
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-09
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Primary Completion: 2014-06
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NEOCD64	blood sample	NEOCD64 : dosage of CD64 blood marker in preterm newborn who are suspected of nosocomial infection (blood sample)

Primary Outcome Measures

Name	Time	Method
proportion of negatives (healthy patient) which are correctly identified as such	day 1

Secondary Outcome Measures

Name	Time	Method
proportion of positives (sikness)which are correctly defined as such	day 1	sensibility of CD64 value
negative predictive CD64 value	day 1
positive predictiveCD64 value	day 1

Trial Locations

Locations (1)

Montpellier University hospital; 🇫🇷 Montpellier, France