Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
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ClinicalTrials.gov Identifier: NCT00646399 |
Recruitment Status :
Completed
First Posted : March 28, 2008
Results First Posted : October 24, 2011
Last Update Posted : October 24, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Staphylococcal Sepsis | Drug: Placebo Drug: Pagibaximab 50 mg/mL | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1579 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Phosphate Buffered Saline
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Drug: Placebo
Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23. |
Experimental: Pagibaximab 50 mg/mL
Pagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23.
|
Drug: Pagibaximab 50 mg/mL
Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23 |
- The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35. [ Time Frame: 35 days ]Safety and efficacy
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Ages Eligible for Study: | up to 48 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- In-patient at a Neonatal Intensive Care Unit (NICU)
- Informed consent obtained from the legally authorized representative
- Less than 48 hours old at the time of first infusion
- Birth weight between 600 grams and 1200 grams
- Estimated gestation age ≤33 weeks
For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group.
Exclusion Criteria:
- Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation.
- Infants with proven staphylococcal infection prior to randomization.
- Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
- Immunodeficiency other than due to prematurity.
- Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study.
- Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study
- Uncontrolled seizures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646399
United States, Maryland | |
Biosynexus Incorporated | |
Gaithersburg, Maryland, United States, 20877 |
Responsible Party: | Biosynexus Incorporated |
ClinicalTrials.gov Identifier: | NCT00646399 |
Other Study ID Numbers: |
MAB-N007 |
First Posted: | March 28, 2008 Key Record Dates |
Results First Posted: | October 24, 2011 |
Last Update Posted: | October 24, 2011 |
Last Verified: | October 2011 |
Staphylococcal Coagulase Negative Staphylococcus Monoclonal antibodies Very Low Birth Weight Infants Prophylaxis |
Sepsis Toxemia Staphylococcal Infections Bacteremia Birth Weight Infections Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Body Weight Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |