Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Standard antimicrobial therapy · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Participants will receive granulocyte transfusions in addition to standard antimicrobial therapy |
| 2 | ACTIVE_COMPARATOR | Participants will receive standard antimicrobial therapy alone |
| 3 | OTHER | Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone |
| Name | Type | Description |
|---|---|---|
| Standard antimicrobial therapy | DRUG | 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 | BIOLOGICAL | 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 | DRUG | Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth. |
| Apheresis machine | DEVICE | 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. |
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 inva...
Standard antimicrobial therapy is used for neutropenia, a condition characterized by an abnormally low count of neutrophils, a type of white blood cell. It is being studied in the context of resolving infections in people with neutropenia, as part of a Phase 3 clinical trial.
Standard antimicrobial therapy is developed by Elevance Health, Inc., a company traded on the stock exchange under the ticker symbol ELV. The company is conducting clinical research on this therapy for the treatment of neutropenia.
Standard antimicrobial therapy is in Phase 3 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The Phase 3 trial, known as the RING Study, has been completed.
Standard antimicrobial therapy has been studied in one clinical trial, identified by the identifier NCT00627393. This Phase 3 trial, titled 'Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)', was conducted in the United States and has been completed.
Yes, the clinical trial for Standard antimicrobial therapy, NCT00627393, was a randomized, active-controlled trial. It was not double-blind, and it enrolled 114 participants with neutropenia and infection. The trial did not select patients based on biomarkers.