- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631800
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110 (N003)
Phase II Randomized, Double Blind, Placebo Controlled, Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110, for the Prevention of Staphylococcal Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Texas Children's Hospital/Ben Taub Hospital (Baylor College of Medicine)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients must meet all of the following criteria at the time of first infusion (Day 0):
- 48-120 hours of age, inclusive
- Birth weight of 700-1300 grams
- Inpatient in a Neonatal Intensive Care Unit
- Written informed consent obtained from the parent(s) or legal guardian
Multiple gestations:
- Siblings from multiple gestations may be enrolled if they each meet the entry criteria
- No more than 4 subjects in any birth weight cohort may be siblings
Exclusion Criteria:
Patients may have none of the following at the first dose:
- Survival not expected for at least 1 week after infusion
- Clinically overt systemic infection, as determined by history, physical examination, and positive culture from a normally sterile site. (Infuse only when infant clinically stable and cultures negative for 48 hours. If being evaluated for sepsis, decision to infuse may be deferred as allowed by protocol infusion window. Infusions outside of protocol window must be approved by Sponsor.)
Severe congenital anomalies or genetic disorders that are likely to be fatal or that may interfere with drug distribution or metabolism, as determined by history and/or physical examination, and including but not limited to:
i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
- Known or suspected hepatic or renal insufficiency
- Clinically uncontrolled seizures
- Immunodeficiency other than due to prematurity
- A history of standard immune globulin administration prior to first study drug infusion (excluding Hepatitis B Immune Globulin, HBIG)
- Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products
- Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study; including enrollment in another investigational study for a product under an IRB-approved protocol
- Expectation that the patient will not be able to be followed for the duration of the study
- Mother with serology positive for hepatitis B surface antigen
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
Other Names:
|
Experimental: 60 mg/kg
60 mg/kg was given on Days 0, 7, 14
|
Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
Other Names:
|
Experimental: 90 mg/kg
90 mg/kg was given on Days 0, 7, 14
|
Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and pharmacokinetics
Time Frame: 0 - 56 days
|
0 - 56 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacodynamics, sepsis/bloodstream infection
Time Frame: 0 - 56 days
|
0 - 56 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MAB-N003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Biosynexus IncorporatedCompletedStaphylococcal SepsisUnited States
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Biosynexus IncorporatedCompletedStaphylococcal SepsisUnited States
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MicroPhage, Inc.CompletedSepsis | Bacteremia | Infection | Staphylococcal InfectionUnited States
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Todd C. Lee MD MPH FIDSANot yet recruitingStaphylococcus Aureus Bacteremia | Staphylococcus Aureus Endocarditis | Staphylococcus Aureus Septicemia | Staphylococcal SepsisCanada
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National Institute of Allergy and Infectious Diseases...CompletedStaphylococcal BacteraemiaUnited States, Canada
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Hospices Civils de LyonWithdrawnStaphylococcal Infection | Streptococcal InfectionFrance
-
Hospices Civils de LyonRecruitingToxic Shock Syndrome StaphylococcalFrance
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University of ChicagoActive, not recruitingStaphylococcus Aureus Infection | Immune Response To SepsisUnited States
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University College, LondonKing's College London; Rambam Health Care Campus; University of Melbourne; Menzies... and other collaboratorsNot yet recruitingSepsis | Staphylococcus Aureus Infection | Bloodstream Infection | Staphylococcus Aureus Bacteremia | Sepsis Bacterial | Staphylococcus Aureus Septicemia | Staph Sepsis
Clinical Trials on Pagibaximab (formerly BSYX-A110)
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Biosynexus IncorporatedCompletedStaphylococcal SepsisUnited States