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Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns (NEOCD64)

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ClinicalTrials.gov Identifier: NCT01951781
Recruitment Status : Unknown
Verified September 2013 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : September 27, 2013
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Nosocomial Infection Other: blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : November 2015

Arm Intervention/treatment
NEOCD64
NEOCD64 : dosage of CD64 blood marker in preterm newborn who are suspected of nosocomial infection (blood sample)
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.





Primary Outcome Measures :
  1. proportion of negatives (healthy patient) which are correctly identified as such [ Time Frame: day 1 ]

Secondary Outcome Measures :
  1. proportion of positives (sikness)which are correctly defined as such [ Time Frame: day 1 ]
    sensibility of CD64 value

  2. negative predictive CD64 value [ Time Frame: day 1 ]
  3. positive predictiveCD64 value [ Time Frame: day 1 ]


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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951781


Contacts
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Contact: Gilles CAMBONIE, Professor 33467336609 g-cambonie@chu-montpellier.fr
Contact: Sabine DURAND, doctor 33467336609 s-durand@chu-montpellier.fr

Locations
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France
Montpellier University hospital Recruiting
Montpellier, France, 34295
Principal Investigator: Gilles Cambonie, Professor         
Sub-Investigator: Sabine Durand, Doctor         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Gilles CAMBONIE, Professor Montpellier hospital

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01951781    
Other Study ID Numbers: 9117
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: September 2013
Keywords provided by University Hospital, Montpellier:
marker CD64
blood sample
nosocomial infection
preterm newborn
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes