Trial Outcomes & Findings for Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis (NCT NCT00646399)
NCT ID: NCT00646399
Last Updated: 2011-10-24
Results Overview
Safety and efficacy
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1579 participants
Primary outcome timeframe
35 days
Results posted on
2011-10-24
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 milestones
| Measure |
Pagibaximab
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
792
|
787
|
|
Overall Study
COMPLETED
|
709
|
713
|
|
Overall Study
NOT COMPLETED
|
83
|
74
|
Reasons for withdrawal
| Measure |
Pagibaximab
|
Placebo
|
|---|---|---|
|
Overall Study
Death
|
63
|
53
|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
|
Overall Study
Other Reason
|
11
|
11
|
Baseline Characteristics
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Baseline characteristics by cohort
| Measure |
Pagibaximab
n=792 Participants
|
Placebo
n=787 Participants
|
Total
n=1579 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
600-900g
|
25.7 Weeks
STANDARD_DEVIATION 1.67 • n=5 Participants
|
25.9 Weeks
STANDARD_DEVIATION 1.83 • n=7 Participants
|
25.8 Weeks
STANDARD_DEVIATION 1.76 • n=5 Participants
|
|
Age Continuous
901-1200g
|
28.0 Weeks
STANDARD_DEVIATION 1.77 • n=5 Participants
|
27.9 Weeks
STANDARD_DEVIATION 1.73 • n=7 Participants
|
28.0 Weeks
STANDARD_DEVIATION 1.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
390 Participants
n=5 Participants
|
393 Participants
n=7 Participants
|
783 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
402 Participants
n=5 Participants
|
394 Participants
n=7 Participants
|
796 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
603 participants
n=5 Participants
|
596 participants
n=7 Participants
|
1199 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
60 participants
n=5 Participants
|
59 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
54 participants
n=5 Participants
|
57 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
25 participants
n=5 Participants
|
28 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
23 participants
n=5 Participants
|
17 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Birth Weight
600-900g
|
758.8 grams
STANDARD_DEVIATION 90.28 • n=5 Participants
|
762.7 grams
STANDARD_DEVIATION 85.05 • n=7 Participants
|
760.7 grams
STANDARD_DEVIATION 87.70 • n=5 Participants
|
|
Birth Weight
901-1200g
|
1047.8 grams
STANDARD_DEVIATION 86.25 • n=5 Participants
|
1039.0 grams
STANDARD_DEVIATION 85.72 • n=7 Participants
|
1043.4 grams
STANDARD_DEVIATION 86.05 • n=5 Participants
|
PRIMARY outcome
Timeframe: 35 daysPopulation: 1579 very low birth weight subjects were included in the ITT.
Safety and efficacy
Outcome measures
| Measure |
Pagibaximab
n=792 Participants
|
Placebo
n=787 Participants
|
|---|---|---|
|
The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.
|
85 Participants
|
79 Participants
|
Adverse Events
Pagibaximab
Serious events: 284 serious events
Other events: 770 other events
Deaths: 0 deaths
Placebo
Serious events: 273 serious events
Other events: 758 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pagibaximab
n=784 participants at risk
|
Placebo
n=778 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Necrotizing Colitis
|
6.6%
52/784 • Number of events 52
|
5.4%
42/778 • Number of events 42
|
|
Nervous system disorders
Intraventricular Haemorrhage
|
7.0%
55/784 • Number of events 56
|
7.3%
57/778 • Number of events 58
|
|
Congenital, familial and genetic disorders
Patent Ductus Arteriosus
|
13.3%
104/784 • Number of events 104
|
14.1%
110/778 • Number of events 110
|
|
Gastrointestinal disorders
Intestinal Perforation
|
3.6%
28/784 • Number of events 28
|
3.3%
26/778 • Number of events 28
|
|
Nervous system disorders
Periventricular Leukomalacia
|
1.8%
14/784 • Number of events 14
|
1.9%
15/778 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Interstitial Emphysema
|
3.3%
26/784 • Number of events 27
|
3.0%
23/778 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
1.1%
9/784 • Number of events 9
|
1.5%
12/778 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
12/784 • Number of events 12
|
0.77%
6/778 • Number of events 6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
18/784 • Number of events 18
|
1.8%
14/778 • Number of events 15
|
|
Cardiac disorders
Bradycardia
|
0.51%
4/784 • Number of events 4
|
0.51%
4/778 • Number of events 4
|
Other adverse events
| Measure |
Pagibaximab
n=784 participants at risk
|
Placebo
n=778 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
61.1%
479/784 • Number of events 646
|
62.6%
487/778 • Number of events 665
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
9/784 • Number of events 9
|
2.2%
17/778 • Number of events 17
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
10.8%
85/784 • Number of events 85
|
10.2%
79/778 • Number of events 79
|
|
Metabolism and nutrition disorders
Feeding Disorder Neonatal
|
26.0%
204/784 • Number of events 221
|
24.9%
194/778 • Number of events 209
|
|
Infections and infestations
Ophthalmia Neonatorum
|
7.1%
56/784 • Number of events 58
|
5.3%
41/778 • Number of events 48
|
|
Investigations
Cardiac Murmur
|
6.1%
48/784 • Number of events 50
|
5.8%
45/778 • Number of events 49
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
16.3%
128/784 • Number of events 137
|
14.4%
112/778 • Number of events 113
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER