Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)
Condition: Neutropenia; Infection
MeSH terms: Infections; Communicable Diseases; Neutropenia
Intervention: Standard antimicrobial therapy; Granulocyte transfusions; G-CSF/dexamethasone; Apheresis machine
Intervention description: 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.; 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).; Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.; 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.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents; Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 114.0
Sex: All
Healthy volunteers: No
Keywords: Granulocyte Transfusions

Summary:

      Neutropenia, a condition characterized by an abnormally low number of infection-fighting
      white blood cells called neutrophils, commonly develops in people who have undergone
      chemotherapy or hematopoietic stem cell (HSC) transplantation. The severely reduced immunity
      of those with neutropenia can put them at risk of entry of life-threatening infections,
      making the implementation of treatments that increase white blood cell numbers important.
      Several studies have shown that the transfusion of donor granulocytes, a type of white blood
      cell that includes neutrophils, is effective in promoting the recovery of adequate numbers of
      granulocytes. However, granulocyte transfusions can cause side effects, and it is not known
      whether the success of the therapy outweighs the health risks of the side effects. This study
      will evaluate the safety and effectiveness of granulocyte transfusions in treating people
      with a bacterial or fungal infection during neutropenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe neutropenia (Absolute Neutrophil Count < 500/mm^3) due to marrow failure caused
             by underlying disease or therapy

          -  Must have one of the following: fungemia; bacteremia; proven or presumptive invasive
             tissue bacterial infection; or proven, probable, or presumptive invasive fungal
             infection

        Exclusion Criteria:

          -  Unlikely to survive 5 days

          -  Evidence that patient will not be neutropenic at least 5 days

          -  Previously enrolled in this study