Recruiting
Phase 1
Phase 2

Talactoferrin

Sponsor:

Agennix

Code:

NCT00854633

Conditions

Nosocomial Infections

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Talactoferrin

Placebo

Study Details

Brief summary:

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

Conditions

Nosocomial Infections

Study ID

NCT00854633

Start date

Jun, 2009

Status verified date

Mar, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 1

Talactoferrin

placebo comparator: 2

Placebo

Interventions

Talactoferrin

Enteral, 150 mg/kg twice per day

Placebo

Oral, twice per day

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 ]

Central Contacts and Locations

Central contacts

Rajesh Malik, MD

713-552-1091rmalik@agennix.com

Locations

Childrens Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Kosair Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

University of Missouri Health Care, Columbia Regional Hospital

Recruiting

Columbia, Missouri, United States, 65201

More Information

Sponsor

Agennix

Last update posted

Mar 15, 2012

Last verified

Mar, 2012

Keywords

  • Pre-term infants
  • Pre-term infants 750 to 1500 grams

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Agennix on 2012-03-15.