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

Nosocomial Infection Clinical Trial

— NOSODIAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701948
• Other study ID #: 4108
• Status: Completed
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: April 2010
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Cross Infection
• Infection
• Nosocomial Infection

Locations

Country	Name	City	State
France	Service de Pédiatrie 2 - Hôpital d'Enfants CHU de Dijon; 10 - bld Maréchal de Lattre de Tassigny	Dijon
France	Service de Pédiatrie 2 - Hôpital de Hautepierre; 1 - Avenue Molière	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection.		48 hours and at 72 hours