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

This study has been completed.

Study NCT00646399 Information provided by Biosynexus Incorporated

First Received on March 26, 2008. Last Updated on October 20, 2011 History of Changes

Results First Received: August 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Staphylococcal Sepsis
Interventions:	Drug: Placebo Drug: Pagibaximab 50 mg/mL

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Pagibaximab	No text entered.
Placebo	No text entered.

Participant Flow: Overall Study

	Pagibaximab	Placebo
STARTED	792	787
COMPLETED	709	713
NOT COMPLETED	83	74
Death	63	53
Withdrawal by Subject	9	10
Other Reason	11	11

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Pagibaximab	No text entered.
Placebo	No text entered.

Baseline Measures

	Pagibaximab	Placebo	Total
Number of Participants [units: participants]	792	787	1579
Age ^[1] [units: Weeks] Mean ± Standard Deviation
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
Gender [units: participants]
Female	390	393	783
Male	402	394	796
Region of Enrollment [units: 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 [units: Participants]
600-900g	381	371	752
901-1200g	411	416	827
Birth Weight [units: grams] Mean ± Standard Deviation
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]	Gestational Age

Outcome Measures

1. Primary:

The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35. [ Time Frame: 35 days ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Irwin Scher, MD
Organization: Biosynexus
phone: 301-330-5800
e-mail: irwinscher@biosynexus.com

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