View Clinical Trial (Medical Research Study)
Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
| City: |
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Louisville |
| State: |
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Kentucky |
| Zip Code: |
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40202 |
| Conditions: |
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Nosocomial Infections |
| Purpose: |
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This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the
incidence of all nosocomial infections in prematurely-born infants.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00854633 |
| Primary Contact: |
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Rajesh Malik, MD
Phone: 713-552-1091
Email: rmalik@agennix.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Louisville, Kentucky 40202
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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