Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 6:47 PM
Study NCT ID:
NCT00854633
Status:
UNKNOWN
Last Update Posted:
2012-03-15
First Post:
2009-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'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': 'C515276', 'term': 'talactoferrin alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-13', 'studyFirstSubmitDate': '2009-03-02', 'studyFirstSubmitQcDate': '2009-03-02', 'lastUpdatePostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)', 'timeFrame': '1-3 months'}], 'secondaryOutcomes': [{'measure': '"NEC Scares", the "Neonatal Sepsis Syndrome"', 'timeFrame': '1-3 months'}, {'measure': 'Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU', 'timeFrame': '1-3 months'}, {'measure': 'Mortality during hospitalization', 'timeFrame': '1-3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pre-term infants', 'Pre-term infants 750 to 1500 grams'], 'conditions': ['Nosocomial Infections']}, 'referencesModule': {'references': [{'pmid': '27260839', 'type': 'DERIVED', 'citation': 'Sherman MP, Adamkin DH, Niklas V, Radmacher P, Sherman J, Wertheimer F, Petrak K. Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants. J Pediatr. 2016 Aug;175:68-73.e3. doi: 10.1016/j.jpeds.2016.04.084. Epub 2016 May 31.'}, {'pmid': '27234409', 'type': 'DERIVED', 'citation': 'Sherman MP, Sherman J, Arcinue R, Niklas V. Randomized Control Trial of Human Recombinant Lactoferrin: A Substudy Reveals Effects on the Fecal Microbiome of Very Low Birth Weight Infants. J Pediatr. 2016 Jun;173 Suppl:S37-42. doi: 10.1016/j.jpeds.2016.02.074.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Birth weights ranging from 750 to 1500 grams\n* Entry before 24 hours of age\n* Informed-consent form signed by parent(s) or legal guardian\n* Able to take liquid medication by mouth or feeding tube\n\nExclusion Criteria\n\n* A major birth defect or malformation syndrome\n* Chromosomal or inherited disorder\n* Proven presence of an immunodeficiency\n* Antenatal exposure to illicit substances\n* Birth asphyxia\n* HIV or other congenital viral, bacterial, or fungal infection\n* Lack of parental consent or refusal of attending neonatologist to allow participation\n* Discretion of the investigator\n* The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support"}, 'identificationModule': {'nctId': 'NCT00854633', 'briefTitle': 'Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Agennix'}, 'officialTitle': 'Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants', 'orgStudyIdInfo': {'id': 'LF-0901'}, 'secondaryIdInfos': [{'id': '1R44HD057744-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R44HD057744-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Talactoferrin', 'interventionNames': ['Drug: Talactoferrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Talactoferrin', 'type': 'DRUG', 'otherNames': ['talactoferrin alfa', 'TLF', 'recombinant human lactoferrin', 'rhLF'], 'description': 'Enteral, 150 mg/kg twice per day', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral, twice per day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Childrens Hospital of Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Kosair Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Louisville Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Missouri Health Care, Columbia Regional Hospital', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'centralContacts': [{'name': 'Rajesh Malik, MD', 'role': 'CONTACT', 'email': 'rmalik@agennix.com', 'phone': '713-552-1091'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agennix', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}