At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,579 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Pagibaximab 50 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis
In Brief
A Phase 3 clinical trial evaluating Placebo and Pagibaximab 50 mg/mL for Staphylococcal Sepsis. Completed, enrolled 1,579 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStaphylococcal Sepsis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartMar 2009
Primary CompletionMay 2011
TodayJul 2026
First PostedMar 28, 2008
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.3 years ago
Interventions
Placebodrug
Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.
Pagibaximab 50 mg/mLdrug
Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23