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

NCT ID: NCT00646399

Last Updated: 2011-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1579 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-05-31

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.

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.

Conditions

Staphylococcal Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Phosphate Buffered Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.

Pagibaximab 50 mg/mL

Pagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23.

Group Type: EXPERIMENTAL

Pagibaximab 50 mg/mL

Intervention Type: DRUG

Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23

Interventions

Placebo

Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.

Intervention Type: DRUG

Pagibaximab 50 mg/mL

Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biosynexus Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biosynexus Incorporated

Gaithersburg, Maryland, United States

Countries

United States

Related Links

http://www.biosynexus.com

Biosynexus Incorporated

Other Identifiers

MAB-N007

Identifier Type: -

Identifier Source: org_study_id