Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
2 other identifiers
interventional
200
1 country
9
Brief Summary
Prevention trial of nosocomial infections in neutropenic prematures with G-CSF
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2002
Typical duration for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedNovember 29, 2007
November 1, 2007
September 13, 2005
November 28, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
survival without infection at 4 weeks after treatment
one month
Secondary Outcomes (1)
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
one month
Study Arms (2)
groupe filigrastin
ACTIVE COMPARATORgroupe placebo
PLACEBO COMPARATORInterventions
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%.
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 Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Xavier Hernandorena
Bayonne, France
Alain Menget
Besançon, 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
Related Publications (1)
Kuhn P, Messer J, Paupe A, Espagne S, Kacet N, Mouchnino G, Klosowski S, Krim G, Lescure S, Le Bouedec S, Meyer P, Astruc D. A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia. J Pediatr. 2009 Sep;155(3):324-30.e1. doi: 10.1016/j.jpeds.2009.03.019. Epub 2009 May 24.
PMID: 19467544DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Messer, MD
Hopitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
March 1, 2002
Study Completion
August 1, 2006
Last Updated
November 29, 2007
Record last verified: 2007-11