Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Agennix

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Nosocomial Infections

Treatments: Drug: Placebo; Drug: Talactoferrin

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00854633

LF-0901

1R44HD057744-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 1 minute to 24 hours old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Talactoferrin

Treatment:

Drug: Talactoferrin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo