Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 9:53 AM
Study NCT ID:
NCT00213759
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-28', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival without infection at 4 weeks after treatment', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'one month'}]}, 'conditionsModule': {'keywords': ['neutropenia', 'prematurity', 'nosocomial infection', 'G-CSF'], 'conditions': ['Neutropenia in Prematures']}, 'referencesModule': {'references': [{'pmid': '19467544', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Prevention trial of nosocomial infections in neutropenic prematures with G-CSF'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Weeks', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\< 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'}, 'identificationModule': {'nctId': 'NCT00213759', 'briefTitle': 'Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF', 'orgStudyIdInfo': {'id': '2712'}, 'secondaryIdInfos': [{'id': '0203222'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'groupe filigrastin', 'interventionNames': ['Drug: filgrastim']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'groupe placebo', 'interventionNames': ['Drug: dextrose 5%']}], 'interventions': [{'name': 'filgrastim', 'type': 'DRUG', 'description': '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%.', 'armGroupLabels': ['groupe filigrastin']}, {'name': 'dextrose 5%', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['groupe placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bayonne', 'country': 'France', 'facility': 'Xavier Hernandorena', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Besançon', 'country': 'France', 'facility': 'Alain Menget', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Jean-Louis Demarquez', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'Bernard Guillois', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Calais', 'country': 'France', 'facility': 'Marie Thieuleux', 'geoPoint': {'lat': 50.95194, 'lon': 1.85635}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'André Labbe', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'facility': 'Jean-Bernard Gouyon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Pierre Andrini', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Jean Messer', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Jean Messer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}}}}