Back to results

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

Primary Purpose

Staphylococcal Sepsis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

Pagibaximab 50 mg/mL

About this trial

This is an interventional treatment trial for Staphylococcal Sepsis focused on measuring Staphylococcal, Coagulase Negative Staphylococcus, Monoclonal antibodies, Very Low Birth Weight Infants, Prophylaxis

Eligibility Criteria

undefined - 48 Hours (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Biosynexus Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Pagibaximab 50 mg/mL

Arm Description

Phosphate Buffered Saline

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

Outcomes

Primary Outcome Measures

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

Safety and efficacy

Secondary Outcome Measures

Full Information

NCT ID

NCT00646399

First Posted

March 26, 2008

Last Updated

October 20, 2011

Sponsor

Biosynexus Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT00646399

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosynexus Incorporated

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staphylococcal Sepsis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1579 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Phosphate Buffered Saline

Arm Title

Pagibaximab 50 mg/mL

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pagibaximab 50 mg/mL

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Safety and efficacy

Time Frame

35 days

10. Eligibility

Sex

All

Maximum Age & Unit of Time

48 Hours

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Biosynexus Incorporated

City

Gaithersburg

State/Province

Maryland

ZIP/Postal Code

20877

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.biosynexus.com

Description

Biosynexus Incorporated

Learn more about this trial

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

We'll reach out to this number within 24 hrs