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Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

NCT00854633 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-03-15

No results posted yet for this 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.

Conditions

  • Nosocomial Infections

Interventions

DRUG

Talactoferrin

Enteral, 150 mg/kg twice per day

DRUG

Placebo

Oral, twice per day

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Agennix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-03-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00854633 on ClinicalTrials.gov