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Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213759
First received: September 13, 2005
Last updated: November 28, 2007
Last verified: November 2007
History of Changes
  Purpose

Prevention trial of nosocomial infections in neutropenic prematures with G-CSF


Condition Intervention Phase
Neutropenia in Prematures
 Drug: filgrastim
Drug: dextrose 5%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • survival without infection at 4 weeks after treatment [ Time Frame: one month ]

Secondary Outcome Measures:
  • survival free of infection at 2 weeks after treatment,mortality, increase of neutrophile, number of septic event, incidence of chronic lung disease, necrotizing enterocolitis, cerebral us abnormalities, retinopathy , duration of hospitalisation stay [ Time Frame: one month ]

Enrollment: 200
Study Start Date: March 2002
Study Completion Date: August 2006
Arms Assigned Interventions
Active Comparator: groupe filigrastin Drug: filgrastim
The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days . The infusion will last from 20 to 40 minutes according to weight of the child and the product will be diluted in dextrose 5%.
Placebo Comparator: groupe placebo Drug: dextrose 5%
The placebo (dextrose 5% ) will be injected by intravenous way with the amount of 0.66 ml/kg during 3 days consecutive. The infusion will last from 20 to 40 minutes.

  Eligibility

Ages Eligible for Study:   up to 35 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

< 33 weeks GA neutropenic during at least 24 hours in the first 3 weeks of life and not infected at time of inclusion < 35 if birth weight < 1500 g

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213759

Locations
France
Xavier Hernandorena
Bayonne, France
Alain Menget
Besancon, France
Jean-Louis Demarquez
Bordeaux, France
Bernard Guillois
Caen, France
Marie Thieuleux
Calais, France
André Labbe
Clermont-Ferrand, France
Jean-Bernard Gouyon
Dijon, France
Pierre Andrini
Grenoble, France
Jean Messer
Strasbourg, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Jean Messer, MD Hopitaux Universitaires de Strasbourg
  More Information

No publications provided by University Hospital, Strasbourg, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00213759     History of Changes
Other Study ID Numbers: 2712, 0203222
Study First Received: September 13, 2005
Last Updated: November 28, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
neutropenia
prematurity
nosocomial infection
G-CSF

Additional relevant MeSH terms:
Neutropenia
Cross Infection
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
 Infection
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013