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Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

This study is currently recruiting participants.
Verified March 2012 by Agennix
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00854633
First received: March 2, 2009
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.


Condition Intervention Phase
Nosocomial Infections
 Drug: Talactoferrin
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Agennix:

Primary Outcome Measures:
  • Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP) [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • "NEC Scares", the "Neonatal Sepsis Syndrome" [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
  • Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
  • Mortality during hospitalization [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Talactoferrin
 Drug: Talactoferrin
Enteral, 150 mg/kg twice per day
Other Names:
  • talactoferrin alfa
  • TLF
  • recombinant human lactoferrin
  • rhLF
Placebo Comparator: 2
Placebo
 Drug: Placebo
Oral, twice per day

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth weights ranging from 750 to 1500 grams
  • Entry before 24 hours of age
  • Informed-consent form signed by parent(s) or legal guardian
  • Able to take liquid medication by mouth or feeding tube

Exclusion Criteria

  • A major birth defect or malformation syndrome
  • Chromosomal or inherited disorder
  • Proven presence of an immunodeficiency
  • Antenatal exposure to illicit substances
  • Birth asphyxia
  • HIV or other congenital viral, bacterial, or fungal infection
  • Lack of parental consent or refusal of attending neonatologist to allow participation
  • Discretion of the investigator
  • The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854633

Contacts
Contact: Rajesh Malik, MD 713-552-1091 rmalik@agennix.com

Locations
United States, California
Childrens Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
United States, Missouri
University of Missouri Health Care, Columbia Regional Hospital Recruiting
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
Agennix
National Institutes of Health (NIH)
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00854633     History of Changes
Other Study ID Numbers: LF-0901, 1R44HD057744-01A1
Study First Received: March 2, 2009
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
Pre-term infants
Pre-term infants 750 to 1500 grams

Additional relevant MeSH terms:
Cross Infection
Infection

ClinicalTrials.gov processed this record on May 19, 2013