Neonatal Intensive Care Studies

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

• The primary objective is to assess the safety, efficacy and pharmacokinetics of Pagibaximab Injection for the prevention of sepsis caused by staphylococci in VLBW infants.
• Recruiting Subjects <48 hours old, weighing 600-1200grams, estimated gestation age <33 weeks, with IV access in place.
• Study lasts 50 days, subjects are given 6 doses of either Pagibaximab or Placebo.
• The primary investigator is Dr. Gunawardene, MD
• Study nurses are Patricia Johnson and Becky Hester (602) 344-5925

 
A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis

• The primary objective is to evaluate the efficacy and safety of micafungin in comparison to amphotericin B deoxycholate (CAB) in the treatment of proven neonatal candidiasis and to further evaluate the pharmacokinetics of micafungin, as well as CAB, in this patient population.
• Recruiting subjects 48 hours – 120 days old with proven candidemia or candiduria
• Study drug (micafungin or amphotericin B) will be given for 21-28 days
• The primary investigator is Dr. Gunawardene, MD
• Study nurses are Patricia Johnson and Becky Hester (602)344-5925

(This study is currently on hold, enrollment is expected to resume October, 2009)

Last updated on December 16, 2009