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Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Primary Purpose

Nosocomial Infections

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Talactoferrin
Placebo
Sponsored by
Agennix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infections focused on measuring Pre-term infants, Pre-term infants 750 to 1500 grams

Eligibility Criteria

1 Minute - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Childrens Hospital of Los AngelesRecruiting
  • Kosair Children's HospitalRecruiting
  • University of Louisville HospitalRecruiting
  • University of Missouri Health Care, Columbia Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Talactoferrin

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

"NEC Scares", the "Neonatal Sepsis Syndrome"
Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU
Mortality during hospitalization

Full Information

First Posted
March 2, 2009
Last Updated
March 13, 2012
Sponsor
Agennix
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00854633
Brief Title
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Official Title
Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agennix
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infections
Keywords
Pre-term infants, Pre-term infants 750 to 1500 grams

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Talactoferrin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Talactoferrin
Other Intervention Name(s)
talactoferrin alfa, TLF, recombinant human lactoferrin, rhLF
Intervention Description
Enteral, 150 mg/kg twice per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral, twice per day
Primary Outcome Measure Information:
Title
Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
"NEC Scares", the "Neonatal Sepsis Syndrome"
Time Frame
1-3 months
Title
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
Title
Mortality during hospitalization
Time Frame
1-3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajesh Malik, MD
Phone
713-552-1091
Email
rmalik@agennix.com
Facility Information:
Facility Name
Childrens Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Health Care, Columbia Regional Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
27260839
Citation
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.
Results Reference
derived
PubMed Identifier
27234409
Citation
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.
Results Reference
derived

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Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

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