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

This study is currently recruiting participants.
Verified April 2010 by University Hospital, Strasbourg, France
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00701948
First received: June 17, 2008
Last updated: April 27, 2010
Last verified: April 2010
History of Changes

June 17, 2008
April 27, 2010
July 2008
December 2013   (final data collection date for primary outcome measure)
Evaluation of new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. [ Time Frame: 48 hours and at 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00701948 on ClinicalTrials.gov Archive Site
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New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn
Interest of New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum
Non-Probability Sample

Newborn hospitalized in neonatal intensive care unit with a clinical suspicion of nosocomial bacterial infection
Nosocomial Infection
Not Provided
  • A-1
    Proven nosocomial bacterial infection (NBI)
  • A-2
    Possible NBI
  • B-1
    Absence of NBI
  • B-2
    Probable absence of NBI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 90 Days
No
Contact: Pierre Kuhn, MD 33 3 88 12 77 86 Pierre.kuhn@chru-strasbourg.fr
France
 
NCT00701948
4108
No
Emmanuel LAVOUE, directeur Adjoint, Organization: University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Study Director: Pierre Kuhn, MD University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP