Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Nosocomial Infections Clinical Trial

Official title:

Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00854633
• Other study ID #: LF-0901
• Secondary ID: 1R44HD057744-01A
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 2, 2009
• Last updated: March 13, 2012
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Agennix
• Contact: Rajesh Malik, MD
• Phone: 713-552-1091
• Email: rmalik[@]agennix.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cross Infection
• Infection
• Nosocomial Infections

Intervention

Drug:
• Talactoferrin
Enteral, 150 mg/kg twice per day
• Placebo
Oral, twice per day

Locations

Country	Name	City	State
United States	University of Missouri Health Care, Columbia Regional Hospital	Columbia	Missouri
United States	Childrens Hospital of Los Angeles	Los Angeles	California
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Agennix	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)		1-3 months	No
Secondary	"NEC Scares", the "Neonatal Sepsis Syndrome"		1-3 months	No
Secondary	Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU		1-3 months	No
Secondary	Mortality during hospitalization		1-3 months	No