Pagibaximab Injection for Prevention of Staph. Sepsis in Neonates

• Research type

  Research Study

• Full title

  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

• IRAS ID

  26880

• Contact name

  Paul Clarke

• Sponsor organisation

  Biosynexus Incorporated

• Eudract number

  2009-011346-26

• Clinicaltrials.gov Identifier

  NCT00646399

• Research summary

  The purpose of this study is to show whether a new experimental drug, Pagibaximab, is safe and can prevent sepsis (the body's response to an infection in the blood) caused by staphylococcal bacteria, in very low birth weight (VLBW) babies. VLBW babies have a high chance of developing sepsis while in the hospital. Bacteria that are normally found in healthy people occasionally invade and infect the bloodstream. When the body tries to fight this infection in the blood, symptoms develop and the person gets sepsis. While many types of germs cause sepsis, over half of the cases of sepsis in VLBW babies are caused by staphylococcal bacteria, sometimes called ??staph? for short. Premature babies are at high risk of sepsis for several reasons. This new study is being conducted to test the safety and effectiveness of Pagibaximab in preventing staph sepsis. About 1550 babies will be enrolled from about 100 hospitals in the U.S., Canada and Europe. Each baby will be enrolled in the study for 50 days, or until hospital discharge, whichever comes first. The study is funded by Biosynexus Incorporated In this study, Pagibaximab will be compared to a placebo (normal saline-saltwater). A placebo is a ??dummy treatment?, which looks like the genuine medicine but contains no active ingredient. The trial is randomized which means that people are put into groups and each group is given a different treatment. The results are compared to see if one is better. To try and make sure the groups are the same to start with, each patient is put into a group by chance (randomly). The trial is also double blind, which means that neither the parents nor the Doctor or Nurses will know which treatment group the baby is in. (although, if the Doctor needs to find out he/she can do so).

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/67

• Date of REC Opinion

  9 Nov 2009

• REC opinion

  Further Information Favourable Opinion