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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

March 2, 2009
March 13, 2012
June 2009
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00854633 on ClinicalTrials.gov Archive Site
  • "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 ]
Same as current
Not Provided
Not Provided
 
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Nosocomial Infections
  • Drug: Talactoferrin
    Enteral, 150 mg/kg twice per day
    Other Names:
    • talactoferrin alfa
    • TLF
    • recombinant human lactoferrin
    • rhLF
  • Drug: Placebo
    Oral, twice per day
  • Experimental: 1
    Talactoferrin
    Intervention: Drug: Talactoferrin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
up to 24 Hours
No
Contact: Rajesh Malik, MD 713-552-1091 rmalik@agennix.com
United States
 
NCT00854633
LF-0901, 1R44HD057744-01A1
Yes
Agennix
Agennix
National Institutes of Health (NIH)
Not Provided
Agennix
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP