114
Participants
Start Date
April 30, 2008
Primary Completion Date
April 30, 2013
Study Completion Date
May 31, 2013
Standard antimicrobial therapy
Antimicrobial therapy is broadly defined as therapy within the standard of care for a particular infection and should be consistent within a given institution. Participants will undergo the recommended therapy for specific infections for 42 days.
Granulocyte transfusions
Participants will receive one granulocyte transfusion per day until one of the following occurs: recovery from neutropenia, life-threatening toxicity, resolution or improvement of infection, or Day 42 after treatment. Granulocyte content of each transfusion is targeted to be at least 4 x 10\^10 per collection (or proportionately less for participants less than 30 kg in weight).
G-CSF/dexamethasone
Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.
Apheresis machine
Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants.
Weill Medical College, Cornell University, New York
Montefiore Medical Center, The Bronx
University of Pittsburgh Presbyterian and Shadyside, Pittsburgh
Chlidren's Hospital of Philadelphia, Philadelphia
University of Pennsylvania, Philadelphia
Johns Hopkins Hospital, Baltimore
University of Iowa Hospitals and Clinics, Iowa City
Froedtert Memorial Lutheran Hospital, Milwaukee
University of Wisconsin at Madison, Madison
University of Minnesota, Minneapolis
University of Oklahoma Health Sciences Center, Oklahoma City
University of Washington Medical Center, Seattle
Children's Hospital Boston, Boston
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Carelon Research
OTHER