CompletedNCT00646399Updated Oct 24, 2011Results posted

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

A Phase 2/3 interventional study of Placebo and Pagibaximab 50 mg/mL in Staphylococcal Sepsis, sponsored by Biosynexus Incorporated. Completed at 1 site in United States. Open to participants aged Up to 48 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-24.

Sponsored by Biosynexus Incorporated · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 1,579
Allocation: Randomized
Ages: Up to 48 Hours
Sex: All

Study 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.

Read the 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 studied

Staphylococcal Sepsis

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Keywords

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

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 1,579 is above the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Biosynexus Incorporated is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 48 Hours
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 1,579 participants (actual)

Study arms

Placebo comparator
Placebo
Phosphate Buffered Saline
Drug: Placebo
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

Interventions

DrugPlacebo
Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.
DrugPagibaximab 50 mg/mL
Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23

What researchers measure

Primary outcomes

The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.
Safety and efficacy
Time frame: 35 days

Results

Posted Oct 24, 2011

Participant flow

The first subject was enrolled on 29 Mar 2009 and the last randomized subject completed the trial on 20 Jan 2011. The trial was conducted in the neonatal intensive care unit.

Participant flow — Overall Study
Milestone	Pagibaximab	Placebo
Started	792	787
Completed	709	713
Not completed	83	74
Withdrew: Death	63	53
Withdrew: Withdrawal by subject	9	10
Withdrew: Other reason	11	11

Outcome measures

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

Safety and efficacy

Time frame:: 35 days
Reported as:: Number · Participants

The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.
Participants	Pagibaximab	Placebo
The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.	85	79

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pagibaximab	—	284/784 (36.2%)	770/784 (98.2%)
Placebo	—	273/778 (35.1%)	758/778 (97.4%)

Most frequent serious events

Most frequent serious events
Event	Pagibaximab	Placebo
Patent Ductus ArteriosusCongenital, familial and genetic disorders	104/784	110/778
Intraventricular HaemorrhageNervous system disorders	55/784	57/778
Necrotizing ColitisGastrointestinal disorders	52/784	42/778
Intestinal PerforationGastrointestinal disorders	28/784	26/778
Pulmonary Interstitial EmphysemaRespiratory, thoracic and mediastinal disorders	26/784	23/778
ThrombocytopeniaBlood and lymphatic system disorders	18/784	14/778
Periventricular LeukomalaciaNervous system disorders	14/784	15/778
Pulmonary HaemorrhageRespiratory, thoracic and mediastinal disorders	9/784	12/778
HyperkalaemiaMetabolism and nutrition disorders	12/784	6/778
BradycardiaCardiac disorders	4/784	4/778

Most frequent other events

Most frequent other events
Event	Pagibaximab	Placebo
AnaemiaBlood and lymphatic system disorders	479/784	487/778
Feeding Disorder NeonatalMetabolism and nutrition disorders	204/784	194/778
HyperbilirubinaemiaHepatobiliary disorders	128/784	112/778
Gastrooesophageal Reflux DiseaseGastrointestinal disorders	85/784	79/778
Ophthalmia NeonatorumInfections and infestations	56/784	41/778
Cardiac MurmurInvestigations	48/784	45/778
HypothyroidismEndocrine disorders	9/784	17/778

Baseline characteristics

Age Continuous
Age Continuous(Weeks)	Pagibaximab	Placebo	Total
600-900g	25.7 ± 1.67	25.9 ± 1.83	25.8 ± 1.76
901-1200g	28.0 ± 1.77	27.9 ± 1.73	28.0 ± 1.75

Sex: Female, Male
Sex: Female, Male(Participants)	Pagibaximab	Placebo	Total
Female	390	393	783
Male	402	394	796

Region of Enrollment
Region of Enrollment(participants)	Pagibaximab	Placebo	Total
United States	603	596	1199
Canada	60	59	119
Spain	54	57	111
Italy	27	30	57
United Kingdom	25	28	53
Germany	23	17	40

Birth Weight
Birth Weight(Participants)	Pagibaximab	Placebo	Total
600-900g	381	371	752
901-1200g	411	416	827

Birth Weight
Birth Weight(grams)	Pagibaximab	Placebo	Total
600-900g	758.8 ± 90.28	762.7 ± 85.05	760.7 ± 87.70
901-1200g	1047.8 ± 86.25	1039.0 ± 85.72	1043.4 ± 86.05

Study locations

1 site

Biosynexus Incorporated
Gaithersburg, Maryland 20877, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00646399
Lead sponsor: Biosynexus Incorporated
Responsible party: Sponsor
First posted: Mar 28, 2008
Start date: Mar 2009
Primary completion: May 2011
Completion: May 2011
Results posted: Oct 24, 2011
Last update: Oct 24, 2011

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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