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Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00646399
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : October 24, 2011
Last Update Posted : October 24, 2011
Information provided by (Responsible Party):
Biosynexus Incorporated

Brief Summary:
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.

Condition or disease Intervention/treatment Phase
Staphylococcal Sepsis Drug: Placebo Drug: Pagibaximab 50 mg/mL Phase 2 Phase 3

Detailed Description:
Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight Sepsis

Arm Intervention/treatment
Placebo Comparator: Placebo
Phosphate Buffered Saline
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

Primary Outcome Measures :
  1. The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35. [ Time Frame: 35 days ]
    Safety and efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. In-patient at a Neonatal Intensive Care Unit (NICU)
  2. Informed consent obtained from the legally authorized representative
  3. Less than 48 hours old at the time of first infusion
  4. Birth weight between 600 grams and 1200 grams
  5. 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:

  1. Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation.
  2. Infants with proven staphylococcal infection prior to randomization.
  3. 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.
  4. Immunodeficiency other than due to prematurity.
  5. Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study.
  6. Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study
  7. Uncontrolled seizures

Information from the National Library of Medicine

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

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United States, Maryland
Biosynexus Incorporated
Gaithersburg, Maryland, United States, 20877
Sponsors and Collaborators
Biosynexus Incorporated
Additional Information:
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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
Keywords provided by Biosynexus Incorporated:
Coagulase Negative Staphylococcus
Monoclonal antibodies
Very Low Birth Weight Infants
Additional relevant MeSH terms:
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Staphylococcal Infections
Birth Weight
Systemic Inflammatory Response Syndrome
Pathologic Processes
Body Weight
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses