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

University Hospital Center (CHU)

Status: Unknown

Conditions: Nosocomial Infection

Treatments: Other: blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT01951781

9117

Details and patient eligibility

About

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.

Enrollment: 153 estimated patients

Sex: All

Ages: Under 5 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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153 participants in 1 patient group

NEOCD64

Other group

Description:

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

Treatment:

Other: blood sample