Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns

Nosocomial Infection Clinical Trial

— NEOCD64  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01951781
• Other study ID #: 9117
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2013
• Last updated: January 8, 2015
• Start date: June 2013
• Est. completion date: November 2015

Study information

• Verified date: September 2013
• Source: University Hospital, Montpellier
• Contact: Gilles CAMBONIE, Professor
• Phone: 33467336609
• Email: g-cambonie[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: November 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Months

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection
• Nosocomial Infection

Intervention

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.

Locations

Country	Name	City	State
France	Montpellier University hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of negatives (healthy patient) which are correctly identified as such		day 1	No
Secondary	proportion of positives (sikness)which are correctly defined as such	sensibility of CD64 value	day 1	No
Secondary	negative predictive CD64 value		day 1	No
Secondary	positive predictiveCD64 value		day 1	No