Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns

NCT01951781 | Unknown DMC

• 1 other identifier: 9117
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Nosocomial Infection

Keywords

marker CD64; blood sample; nosocomial infection; preterm newborn

Outcome Measures

Primary Outcomes (1)

• proportion of negatives (healthy patient) which are correctly identified as such

  day 1

Secondary Outcomes (3)

• proportion of positives (sikness)which are correctly defined as such

  day 1

• negative predictive CD64 value

  day 1

• positive predictiveCD64 value

  day 1

Study Arms (1)

NEOCD64

OTHER

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

Other: blood sample

Interventions

blood sample OTHER

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.

NEOCD64

Eligibility Criteria

• Age: Up to 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm newborn (\<37 weeks of gestationnal age )
• undergoing symptoms of late-onset-sepsis
• written informed consent obtained from the parents

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Cross Infection

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gilles CAMBONIE, Professor

  Montpellier hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles CAMBONIE, Professor

CONTACT

33467336609; g-cambonie@chu-montpellier.fr

Sabine DURAND, doctor

CONTACT

33467336609; s-durand@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 27, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2015
• Last Updated: January 9, 2015

Record last verified: 2013-09

Locations

FR (1)