Grant: Project Grant
Queen's University (Kingston, Ontario)
$1,197,227.00
RATIONAL (Role of Antibiotic Therapy or Immunoglobulin On iNfection in hAematoLogy) Platform Trial: An RCT of continuing immunoglobulin therapy, or stopping with or without prophylactic antibiotics, on infection rate in patients with acquired hypogammaglobulinemia secondary to haematological malignancies
FY 2024-25
Summary
This study is being done in patients with low antibody blood levels and blood cancers. Antibodies are immune proteins that help prevent infections. Low antibody levels are common in patients with blood cancers. Low antibody levels increase the susceptibility to infections. These infections lead to admissions to hospital for intravenous antibiotics, side effects from antibiotics, extra investigations to determine the location of the infection (x-rays, blood tests), delays in chemotherapy, and rarely, death from infection. Identifying treatments to prevent infection is therefore a priority. The most common preventative treatments are immunoglobulin replacement (IgRT) and oral antibiotics. IgRT is a blood product infused monthly at the hospital over 4 hours or through slow twice weekly self-injections at home. IgRT is expensive and costs about $30,000 per patient per year. This recommendation is based on small studies from the 1980s and there is no evidence that IgRT improves outcomes when compared to preventative antibiotics. It is uncertain which patients should receive IgRT, what dose should be given, when it should be started, and when it is can be safely stopped. Similar evidence gaps exist for use of preventative daily home antibiotics (taken by mouth). A small study of 63 patients compared standard dose IgRT to daily oral antibiotics and found similar rates of infection, but improved patient quality of life and lower costs with antibiotics. Clinical studies are required to understand for sure which treatment is best. The objective of this trial is to compare standard dose IgRT, with low-dose IgRT or oral antibiotics to prevent serious infection and death. The trial will measure infection rates, antibiotic resistance, IgRT and antibiotic side effects, patient quality of life, and healthcare costs.
Department
Program
Project Grant
Location
Ontario, Canada
Type
Grant
Source
CIHR Funding Decisions Database
As published
Id
507295
Name
Callum Jeannie L
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Infection and Immunity
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
RATIONAL (Role of Antibiotic Therapy or Immunoglobulin On iNfection in hAematoLogy) Platform Trial: An RCT of continuing immunoglobulin therapy, or stopping with or without prophylactic antibiotics, on infection rate in patients with acquired hypogammaglobulinemia secondary to haematological malignancies
Programtype2
Operating Grants
Orgnameinp2
Queen's University (Kingston, Ontario)
Cihramount2
$1,197,227
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Adaptive Platform Trial; Antibiotic Therapy; Hematologic Malignancies; Hypogammaglobulinemia; Immunoglobulin; Infections
Abstract
This study is being done in patients with low antibody blood levels and blood cancers. Antibodies are immune proteins that help prevent infections. Low antibody levels are common in patients with blood cancers. Low antibody levels increase the susceptibility to infections. These infections lead to admissions to hospital for intravenous antibiotics, side effects from antibiotics, extra investigations to determine the location of the infection (x-rays, blood tests), delays in chemotherapy, and rarely, death from infection. Identifying treatments to prevent infection is therefore a priority. The most common preventative treatments are immunoglobulin replacement (IgRT) and oral antibiotics. IgRT is a blood product infused monthly at the hospital over 4 hours or through slow twice weekly self-injections at home. IgRT is expensive and costs about $30,000 per patient per year. This recommendation is based on small studies from the 1980s and there is no evidence that IgRT improves outcomes when compared to preventative antibiotics. It is uncertain which patients should receive IgRT, what dose should be given, when it should be started, and when it is can be safely stopped. Similar evidence gaps exist for use of preventative daily home antibiotics (taken by mouth). A small study of 63 patients compared standard dose IgRT to daily oral antibiotics and found similar rates of infection, but improved patient quality of life and lower costs with antibiotics. Clinical studies are required to understand for sure which treatment is best. The objective of this trial is to compare standard dose IgRT, with low-dose IgRT or oral antibiotics to prevent serious infection and death. The trial will measure infection rates, antibiotic resistance, IgRT and antibiotic side effects, patient quality of life, and healthcare costs.
Competitiondate
202409
Approvedterm2
4 yrs 6 mths
Pinamesdelim
Callum, Jeannie L; Reiman, Tony
Approvedterm
4 ans 6 mois
Cihrcontribution2
~ $1,197,227~ $0~