Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns
NCT ID: NCT01951781
Last Updated: 2015-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
153 participants
INTERVENTIONAL
2013-06-30
2015-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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NEOCD64
NEOCD64 : dosage of CD64 blood marker in preterm newborn who are suspected of nosocomial infection (blood sample)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* undergoing symptoms of late-onset-sepsis
* written informed consent obtained from the parents
Exclusion Criteria
* 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
5 Months
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Gilles CAMBONIE, Professor
Role: PRINCIPAL_INVESTIGATOR
Montpellier hospital
Locations
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Montpellier University hospital
Montpellier, , France
Countries
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Central Contacts
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Other Identifiers
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9117
Identifier Type: -
Identifier Source: org_study_id
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