Trial · NCT00646399

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

NCT00646399, Phase 2, Phase 3, Completed, Biosynexus Incorporated; results first posted 2011-10-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis. Trials, record NCT00646399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00646399

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
NCT number: NCT00646399
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 1,579 participants, actual
Lead sponsor: Biosynexus Incorporated
Conditions: Staphylococcal Sepsis
Interventions: Placebo, Pagibaximab 50 mg/mL
First posted: 2008-03-28
Last updated: 2011-10-24
Results first posted: 2011-10-24

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.	35 days	1579 very low birth weight subjects were included in the ITT.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.	Pagibaximab		85		Participants
The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.	Placebo		79		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pagibaximab	792
Overall Study	STARTED	Placebo	787
Overall Study	COMPLETED	Pagibaximab	709
Overall Study	COMPLETED	Placebo	713
Overall Study	NOT COMPLETED	Pagibaximab	83
Overall Study	NOT COMPLETED	Placebo	74

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Pagibaximab	479	784	646
other	Anaemia	Blood and lymphatic system disorders	Placebo	487	778	665
other	Hypothyroidism	Endocrine disorders	Pagibaximab	9	784	9
other	Hypothyroidism	Endocrine disorders	Placebo	17	778	17
other	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Pagibaximab	85	784	85
other	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Placebo	79	778	79
other	Feeding Disorder Neonatal	Metabolism and nutrition disorders	Pagibaximab	204	784	221
other	Feeding Disorder Neonatal	Metabolism and nutrition disorders	Placebo	194	778	209
other	Ophthalmia Neonatorum	Infections and infestations	Pagibaximab	56	784	58
other	Ophthalmia Neonatorum	Infections and infestations	Placebo	41	778	48

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pagibaximab
Total, all-cause mortality	Placebo
Total, other adverse events	Pagibaximab	770	784
Total, other adverse events	Placebo	758	778
Total, serious adverse events	Pagibaximab	284	784
Total, serious adverse events	Placebo	273	778

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pagibaximab vs Placebo: The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.	Trial comparisons
Pagibaximab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00646399

GET https://conductscience.org/api/trials/v1/NCT00646399/events?page=2

API reference For AI assistants