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

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ClinicalTrials.gov Identifier: NCT00646399
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : October 24, 2011
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):
Biosynexus Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Staphylococcal Sepsis
Interventions Drug: Placebo
Drug: Pagibaximab 50 mg/mL
Enrollment 1579
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Pagibaximab Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 792 787
Completed 709 713
Not Completed 83 74
Reason Not Completed
Death             63             53
Withdrawal by Subject             9             10
Other Reason             11             11
Arm/Group Title Pagibaximab Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 792 787 1579
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 792 participants 787 participants 1579 participants
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)
[1]
Measure Description: Gestational Age
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 792 participants 787 participants 1579 participants
Female
390
  49.2%
393
  49.9%
783
  49.6%
Male
402
  50.8%
394
  50.1%
796
  50.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 792 participants 787 participants 1579 participants
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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 792 participants 787 participants 1579 participants
600-900g 381 371 752
901-1200g 411 416 827
Birth Weight  
Mean (Standard Deviation)
Unit of measure:  Grams
Number Analyzed 792 participants 787 participants 1579 participants
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)
1.Primary Outcome
Title The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.
Hide Description Safety and efficacy
Time Frame 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
1579 very low birth weight subjects were included in the ITT.
Arm/Group Title Pagibaximab Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 792 787
Measure Type: Number
Unit of Measure: Participants
85 79
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pagibaximab Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Pagibaximab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pagibaximab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   284/784 (36.22%)      273/778 (35.09%)    
Blood and lymphatic system disorders     
Thrombocytopenia   18/784 (2.30%)  18 14/778 (1.80%)  15
Cardiac disorders     
Bradycardia   4/784 (0.51%)  4 4/778 (0.51%)  4
Congenital, familial and genetic disorders     
Patent Ductus Arteriosus   104/784 (13.27%)  104 110/778 (14.14%)  110
Gastrointestinal disorders     
Necrotizing Colitis   52/784 (6.63%)  52 42/778 (5.40%)  42
Intestinal Perforation   28/784 (3.57%)  28 26/778 (3.34%)  28
Metabolism and nutrition disorders     
Hyperkalaemia   12/784 (1.53%)  12 6/778 (0.77%)  6
Nervous system disorders     
Intraventricular Haemorrhage   55/784 (7.02%)  56 57/778 (7.33%)  58
Periventricular Leukomalacia   14/784 (1.79%)  14 15/778 (1.93%)  15
Respiratory, thoracic and mediastinal disorders     
Pulmonary Interstitial Emphysema   26/784 (3.32%)  27 23/778 (2.96%)  25
Pulmonary Haemorrhage   9/784 (1.15%)  9 12/778 (1.54%)  12
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pagibaximab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   770/784 (98.21%)      758/778 (97.43%)    
Blood and lymphatic system disorders     
Anaemia   479/784 (61.10%)  646 487/778 (62.60%)  665
Endocrine disorders     
Hypothyroidism   9/784 (1.15%)  9 17/778 (2.19%)  17
Gastrointestinal disorders     
Gastrooesophageal Reflux Disease   85/784 (10.84%)  85 79/778 (10.15%)  79
Hepatobiliary disorders     
Hyperbilirubinaemia   128/784 (16.33%)  137 112/778 (14.40%)  113
Infections and infestations     
Ophthalmia Neonatorum   56/784 (7.14%)  58 41/778 (5.27%)  48
Investigations     
Cardiac Murmur   48/784 (6.12%)  50 45/778 (5.78%)  49
Metabolism and nutrition disorders     
Feeding Disorder Neonatal   204/784 (26.02%)  221 194/778 (24.94%)  209
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Irwin Scher, MD
Organization: Biosynexus
Phone: 301-330-5800
Responsible Party: Biosynexus Incorporated
ClinicalTrials.gov Identifier: NCT00646399     History of Changes
Other Study ID Numbers: MAB-N007
First Submitted: March 26, 2008
First Posted: March 28, 2008
Results First Submitted: August 22, 2011
Results First Posted: October 24, 2011
Last Update Posted: October 24, 2011