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Status unknownNCT00854633Updated Mar 15, 2012

Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

A Phase 1/2 interventional study of Talactoferrin and Placebo in Nosocomial Infections, sponsored by Agennix. Status unknown at 4 sites in United States. Open to participants aged 1 Minute to 24 Hours. Per ClinicalTrials.gov, last updated 2012-03-15.

Sponsored by Agennix · Phase 1/2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
1 Minute to 24 Hours
Sex
All
01

Study summary

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

02

Conditions studied

  • Nosocomial Infections

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Keywords

  • Pre-term infants
  • Pre-term infants 750 to 1500 grams
03

In context

Cross Infection

245 studies on the registry are indexed under Cross Infection; 48 are open to participants now.

This study's planned enrollment of 120 is below the median of 204 across 146 interventional studies indexed under Cross Infection.

Browse Cross Infection studies →

Lead sponsor

Agennix is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    1

    Talactoferrin

    Drug: Talactoferrin

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugTalactoferrin

    Enteral, 150 mg/kg twice per day

    Also known as: talactoferrin alfa, TLF, recombinant human lactoferrin, rhLF

  • DrugPlacebo

    Oral, twice per day

06

What researchers measure

Primary outcomes

  1. Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)

    Time frame: 1-3 months

Secondary outcomes

  1. "NEC Scares", the "Neonatal Sepsis Syndrome"

    Time frame: 1-3 months

  2. 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

  3. Mortality during hospitalization

    Time frame: 1-3 months

07

Study locations

4 of 4 sites recruiting
  • Childrens Hospital of Los Angeles
    Los Angeles, California 90027, United States
    Recruiting
  • Kosair Children's Hospital
    Louisville, Kentucky 40202, United States
    Recruiting
  • University of Louisville Hospital
    Louisville, Kentucky 40202, United States
    Recruiting
  • University of Missouri Health Care, Columbia Regional Hospital
    Columbia, Missouri 65201, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27260839 ↗
  • 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. PubMed 27234409 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00854633
Lead sponsor
Agennix
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Mar 3, 2009
Start date
Jun 2009
Primary completion
Mar 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Mar 15, 2012

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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