An observational study in Hematological Malignancy, Hematopoetic Stem Cell Transplantation and Bloodstream Infection, sponsored by Hamad Medical Corporation. Recruiting at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Hamad Medical Corporation · Observational
The goal of this prospective observational study is to is to prospectively study the epidemiology of bloodstream infection (BSI) in patients with hematological malignancies (HM) and hematopoietic stem cell transplant (HSCT) recipients across the Middle East.
The objectives are to describe the epidemiological trends, identify risk factors for inappropriate antimicrobial therapy, and predictors of persistent BSI, microbiological relapse, and all-cause mortality.
The study is entirely observational, participants will receive standard clinical care as directed by their treating doctors.
The study includes centers in Qatar, Saudi Arabia, Oman, the United Arab Emirates and Jordan. Patients age 18 years or more, who have an underlying hematological malignancy (HM) or past hematopoietic stem cell transplantation (HSCT), and experience a bloodstream infection (BSI) will be prospectively enrolled. Each participating center will enroll up to 100 BSI episodes.
Data collection will include demographics, clinical characteristics of the underlying HM and/or HSCT, Charlson Co-morbidity Score, Pitt bacteremia score, vital signs, baseline laboratory findings, suspected source of infection, the presence of any vascular lines or other prosthesis, invasive procedures, immune modulating/suppressive therapy; date, species, antimicrobial susceptibility, resistance genes of blood culture isolates, antimicrobial management (empiric and targeted), and need for critical care support (including vasopressor support, renal replacement, and/or mechanical ventilation). Follow up will include clinical and laboratory parameters and microbiological investigations up to 30 days after the date of the index blood culture.
Coded, de-identified data will be uploaded through a secure electronic data capture tool (Caster EDC). Access is controlled by the Principal Investigator.
Outcomes include:
Descriptive results for quantitative variables will be presented as the mean and standard deviation or median with interquartile range, depending of data distribution. Numbers (percentage) will be reported for qualitative variables. Bivariate analysis will be performed using Independent Sample t-test or Mann Whitney U-test for quantitative variables, and Chi-Square test or Fisher Exact test for qualitative variables.
BSI incidence per 1,000 patient days will be reported, with 95% confidence intervals. Logistic regression models will be used to identify associations with inappropriate empiric therapy, and persistent BSI. Kaplan-Meier survival curves with log-rank P values will be used to assess time to microbiological relapse and all-cause mortality. In addition, Cox proportional hazards will be used to identify independent predictors of microbiological relapse and all-cause mortality.
All statistical analyses will be performed on Stata Statistical Software (StataCorp., College Station, Texas).
This will be an entirely observational study without any direct or indirect intervention, with appropriate confidentiality protection measures. IRB has granted a waiver of informed consent for this project.
1,497 studies on the registry are indexed under Hematologic Neoplasms; 441 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 332 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 30, 2026. See what changed
Adults, aged 18 years or more, with active hematological malignancy or past receipt of hematopoietic stem cell transplant.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Bloodstream infection
Other: No Intervention: Observational Cohort
The study does not involve any investigational interventions. Participants will receive standard clinical care.
Overall bloodstream infection incidence per 1,000 patient days
Overall bloodstream infection incidence per 1,000 patient days
Time frame: 30 days
Persistent bloodstream infection
The isolation of the same clinically significant microorganism(s) from blood cultures collected ≥7 days after the index blood culture.
Time frame: 30 days
Microbiological relapse
The recovery of the same species as that isolated from the index blood culture from a blood culture drawn anytime between discontinuation of active therapy for the index culture and the end of follow up.
Time frame: 90 days
All-cause mortality
All-cause mortality
Time frame: 30 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Will depend on organizational policies and permissions.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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