New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn (NOSODIAG)

University Hospital, Strasbourg, France

Status: Completed

Conditions: Nosocomial Infection

Study type: Observational

Funder types: Other

Identifiers

NCT00701948

4108

Details and patient eligibility

About

This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new dosages or new inflammatory markers could be more useful than dosage of inflammatory markers already used in clinical practice (especially the use of a combination of interleukins (6 or 8) and C-reactive protein for the management of newborns with a clinical suspicion of nosocomial bacterial infection and especially could allow to avoid excessive treatment with antibiotics

Enrollment: 240 patients

Sex: All

Ages: 72 hours to 90 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborns > 72 hours of life hospitalized in neonatal intensive or intermediate care unit presenting a clinical suspicion of NBI

Exclusion criteria

• Early post-operative period ( surgery of less than 48 hours)
• Multiple malformations
• Newborn already included in the study for a previous septic events
• Newborn treated with antibiotics in the last 24 hours

Trial design

240 participants in 4 patient groups

A-1

Description:

Proven nosocomial bacterial infection (NBI)

A-2

Description:

Possible NBI

B-1

Description:

Absence of NBI

B-2

Description:

Probable absence of NBI