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

Sponsor:	Biosynexus Incorporated
Information provided by (Responsible Party):	Biosynexus Incorporated
ClinicalTrials.gov Identifier:	NCT00646399

Purpose

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	Intervention	Phase
Staphylococcal Sepsis	Drug: Placebo Drug: Pagibaximab 50 mg/mL	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Pagibaximab

U.S. FDA Resources

Further study details as provided by Biosynexus Incorporated:

Primary Outcome Measures:

The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35. [ Time Frame: 35 days ] [ Designated as safety issue: No ]
Safety and efficacy

Enrollment:	1579
Study Start Date:	March 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	up to 48 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646399

Locations

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

Sponsors and Collaborators

Biosynexus Incorporated

More Information

Additional Information:

Biosynexus Incorporated This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Biosynexus Incorporated
ClinicalTrials.gov Identifier:	NCT00646399 History of Changes
Other Study ID Numbers:	MAB-N007
Study First Received:	March 26, 2008
Results First Received:	August 22, 2011
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosynexus Incorporated:

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

Additional relevant MeSH terms:

Birth Weight
Sepsis
Toxemia
Staphylococcal Infections
Bacteremia
Body Weight
Signs and Symptoms

Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 12, 2012