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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
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
  Purpose
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

Condition
Nosocomial Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interest of New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Serum

Estimated Enrollment: 240
Study Start Date: July 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
A-1
Proven nosocomial bacterial infection (NBI)
A-2
Possible NBI
B-1
Absence of NBI
B-2
Probable absence of NBI

  Eligibility

Ages Eligible for Study:   up to 90 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newborn hospitalized in neonatal intensive care unit with a clinical suspicion of nosocomial bacterial infection
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701948

Locations
France
Service de Pédiatrie 2 - Hôpital d'Enfants CHU de Dijon; 10 - bld Maréchal de Lattre de Tassigny
Dijon, France, 21079
Service de Pédiatrie 2 - Hôpital de Hautepierre; 1 - Avenue Molière
Strasbourg, France, 67 092
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Pierre Kuhn, MD University Hospital, Strasbourg, France
  More Information

Responsible Party: Emmanuel LAVOUE, directeur Adjoint, Organization: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00701948     History of Changes
Other Study ID Numbers: 4108 
Study First Received: June 17, 2008
Last Updated: April 27, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Late onset neonatal sepsis
Nosocomial bacterial infection
Inflammatory markers
multiplex dosage

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on December 08, 2016