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NCT00627393 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)
A Phase 3 study of Infection and Neutropenia, sponsored by Carelon Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
- 13
- Study locations
NCT00627393: Completed Phase 3 study of Infection and Neutropenia, sponsored by Carelon Research.
NCT00627393 is a Phase 3 study of Infection and Neutropenia that has completed, run by Carelon Research. The registered enrollment target is 114 participants, below the 724-participant average among 41 other Infection trials with a reported enrollment target (84% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00627393, a Phase 3 study of Infection and Neutropenia, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
Microbial response was defined as follows: * A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia. * Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization.
Conditions Studied
Interventions
- DRUG Standard antimicrobial therapy
- BIOLOGICAL Granulocyte transfusions
- DRUG G-CSF/dexamethasone
- DEVICE Apheresis machine
Study Locations (13)
Pennsylvania
- Chlidren's Hospital of Philadelphia - Philadelphia
- University of Pennsylvania - Philadelphia
- University of Pittsburgh Presbyterian and Shadyside - Pittsburgh
New York
- Weill Medical College, Cornell University - New York
- Montefiore Medical Center - The Bronx
Wisconsin
- University of Wisconsin at Madison - Madison
- Froedtert Memorial Lutheran Hospital - Milwaukee
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Maryland
- Johns Hopkins Hospital - Baltimore
Massachusetts
- Children's Hospital Boston - Boston
Minnesota
- University of Minnesota - Minneapolis
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT00627393 record still lists
NCT00627393 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 724-participant average among 41 other Infection trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Infection appearing as the primary indexed condition, and to 4 interventions - of which Standard antimicrobial therapy is the first listed.
NCT00627393 lists 13 locations in 9 states (Pennsylvania, New York, Wisconsin).
Frequently Asked Questions
What is clinical trial NCT00627393 about?
NCT00627393 is a clinical study titled "Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)". 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...
What is the current status of trial NCT00627393?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2008-04. Estimated completion is 2013-05.
What conditions does trial NCT00627393 study?
This clinical trial studies the following conditions: Infection, Neutropenia.
What interventions are being tested in trial NCT00627393?
The interventions under investigation include: Standard antimicrobial therapy (DRUG), Granulocyte transfusions (BIOLOGICAL), G-CSF/dexamethasone (DRUG), Apheresis machine (DEVICE).
Who is sponsoring clinical trial NCT00627393?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00627393 being conducted?
This trial has 13 study locations across Iowa, Maryland, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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114 24th of 41 higher than 18 of 41 other Infection trials
participants (enrollment target), bucketed by value
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