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

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

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcal Sepsis
• Intervention / Treatment: Drug: Placebo; Drug: Pagibaximab 50 mg/mL

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.

• Study Type: Interventional
• Enrollment (Actual): 1579
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • Biosynexus Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.	Safety and efficacy	35 days

Collaborators and Investigators

• Sponsor: Biosynexus Incorporated

Publications and helpful links

Helpful Links

• Biosynexus Incorporated

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: March 26, 2008
• First Submitted That Met QC Criteria: March 26, 2008
• First Posted (Estimate): March 28, 2008

Study Record Updates

• Last Update Posted (Estimate): October 24, 2011
• Last Update Submitted That Met QC Criteria: October 20, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Prophylaxis; Monoclonal antibodies; Staphylococcal; Very Low Birth Weight Infants; Coagulase Negative Staphylococcus
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Body Weight; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Sepsis; Toxemia; Bacteremia; Birth Weight; Staphylococcal Infections
• Other Study ID Numbers: MAB-N007