Comparison of Enhanced Molecular-Level Microbiological Surveillance and Ceftriaxone Prophylaxis in Patients Undergoing Hematopoietic Cell Transplantation: A Randomized, Prospective Medical Experiment

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn whether close microbiological monitoring without preventive antibiotics works as well as preventive treatment with ceftriaxone in adults receiving stem cell transplants. The study focuses on people with blood cancers or other conditions who need either autologous or allogeneic hematopoietic stem cell transplantation (HSCT). The main questions the study aims to answer are: What percentage of participants develop an infection when they do not receive preventive antibiotics compared with those who receive daily ceftriaxone? Does preventive ceftriaxone lower the chance of specific complications such as bloodstream infections, pneumonia, or severe sepsis? Researchers will compare two groups: one group will not receive preventive antibiotics one group will receive ceftriaxone once a day until their white blood cells recover or until signs of infection appear All participants will: have their body temperature monitored continuously starting one day before the transplant have blood, urine, or other samples collected if they develop fever or symptoms of infection receive standard medical care during and after the transplant start standard antibiotic treatment if they develop signs of infection This study will include 100 adults. The information collected will help determine whether skipping preventive antibiotics is safe in hospitals where bacteria often show resistance to commonly used drugs such as fluoroquinolones.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Recipient of autologous or allogeneic hematopoietic stem cells from peripheral blood, bone marrow, or cord blood.

• Age ≥18 years.

• Ability to provide written informed consent.

• No active infection for at least 2 weeks prior to transplantation.

Locations
Other Locations
Poland
Uniwersytecki zpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego Pomorskiego Uniwersytetu Medycznego w Szczecinie
RECRUITING
Szczecin
Contact Information
Primary
Sławomir Milczarek, MD
slawomir.milczarek@pum.edu.pl
+48 881 241 284
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 100
Treatments
Experimental: Ceftriaxone Prophylaxis
Participants assigned to this arm will receive prophylactic ceftriaxone 1 g intravenously once daily, administered at a fixed morning time, starting 24 hours before hematopoietic stem cell infusion (Day -1) and continued until neutrophil recovery or the onset of infection symptoms. All participants undergo continuous body temperature monitoring and standardized microbiological diagnostics in case of fever or suspected infection.
No_intervention: No Prophylaxis
Participants in this arm will not receive prophylactic antibacterial therapy. They will undergo the same continuous body temperature monitoring as the intervention group. In case of fever or other indicators of infection, full microbiological diagnostics will be initiated and empirical antibiotic therapy will be started according to clinical judgment and local epidemiology.
Related Therapeutic Areas
Sponsors
Leads: Pomeranian Medical University Szczecin

This content was sourced from clinicaltrials.gov