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

NCT00646399 | Completed Phase 2 Results DMC

• 1 other identifier: MAB-N007
• Study Type: interventional
• Target: 1,579
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcal Sepsis

Keywords

Staphylococcal; Coagulase Negative Staphylococcus; Monoclonal antibodies; Very Low Birth Weight Infants; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.

  Safety and efficacy

  35 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Phosphate Buffered Saline

Drug: Placebo

Pagibaximab 50 mg/mL

EXPERIMENTAL

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

Drug: Pagibaximab 50 mg/mL

Interventions

Placebo DRUG

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

Placebo

Pagibaximab 50 mg/mL DRUG

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

Pagibaximab 50 mg/mL

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosynexus Incorporated: lead

Study Sites (1)

Biosynexus Incorporated

Gaithersburg, Maryland, 20877, United States

Location

Related Links

• Biosynexus Incorporated

MeSH Terms

Interventions

pagibaximab

Results Point of Contact

• Title: Irwin Scher, MD
• Organization: Biosynexus

irwinscher@biosynexus.com

301-330-5800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 28, 2008
• Study Start: March 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 24, 2011
• Results First Posted: October 24, 2011

Record last verified: 2011-10

Locations

US (1)