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Immunomodulator
1 for Hospital Acquired Infections
Phase 1 & 2
Waitlist Available
Research Sponsored by Agennix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-3 months
Awards & highlights
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.
Eligible Conditions
- Hospital Acquired Infections
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Talactoferrin
Group II: 2Placebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lactoferrin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
AgennixLead Sponsor
19 Previous Clinical Trials
4,019 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,101 Total Patients Enrolled
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