Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

March 13, 2012 updated by: Agennix

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Childrens Hospital of Los Angeles
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville Hospital
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Kosair Children's Hospital
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • University of Missouri Health Care, Columbia Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Oral, twice per day
Experimental: 1
Talactoferrin
Drug: Talactoferrin
Enteral, 150 mg/kg twice per day
Other Names:
  • talactoferrin alfa
  • TLF
  • recombinant human lactoferrin
  • rhLF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)
Time Frame: 1-3 months
1-3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
"NEC Scares", the "Neonatal Sepsis Syndrome"
Time Frame: 1-3 months
1-3 months
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
1-3 months
Mortality during hospitalization
Time Frame: 1-3 months
1-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agennix

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LF-0901
  • 1R44HD057744-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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