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

Staphylococcal Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646399
• Other study ID #: MAB-N007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 26, 2008
• Last updated: October 20, 2011
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: Biosynexus Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1579
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia
• Birth Weight
• Sepsis
• Staphylococcal Infections
• Staphylococcal Sepsis

Intervention

Drug:
• Placebo
Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.
• Pagibaximab 50 mg/mL
Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23

Locations

Country	Name	City	State
United States	Biosynexus Incorporated	Gaithersburg	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Biosynexus Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.	Safety and efficacy	35 days	No