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

NCT00701948 | Completed

• 1 other identifier: 4108
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nosocomial Infection

Keywords

Late onset neonatal sepsis; Nosocomial bacterial infection; Inflammatory markers; multiplex dosage

Outcome Measures

Primary Outcomes (1)

• Evaluation of new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection.

  48 hours and at 72 hours

Study Arms (4)

A-1

Proven nosocomial bacterial infection (NBI)

A-2

Possible NBI

B-1

Absence of NBI

B-2

Probable absence of NBI

Eligibility Criteria

• Age: 72 Hours - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn hospitalized in neonatal intensive care unit with a clinical suspicion of nosocomial bacterial infection

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (2)

Service de Pédiatrie 2 - Hôpital d'Enfants CHU de Dijon; 10 - bld Maréchal de Lattre de Tassigny

Dijon, 21079, France

Location

Service de Pédiatrie 2 - Hôpital de Hautepierre; 1 - Avenue Molière

Strasbourg, 67 092, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Cross Infection; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Pierre Kuhn, MD

  University Hospital, Strasbourg, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 5, 2020

Record last verified: 2010-04

Locations

FR (2)