Nosocomial Infection Clinical Trial
Official title:
Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns
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.
n/a
Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
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