Close microbiological monitoring versus daily ceftriaxone to prevent infections after stem cell transplant
Official title: Comparison of Enhanced Molecular-Level Microbiological Surveillance and Ceftriaxone Prophylaxis in Patients Undergoing Hematopoietic Cell Transplantation: A Randomized, Prospective Medical Experiment
Run by Pomeranian Medical University Szczecin · NCT07308457 · Data updated 2026-11-12
This project tests whether careful microbiological monitoring without preventive antibiotics works as well as daily ceftriaxone to prevent infections in adults receiving hematopoietic stem cell transplants.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Pomeranian Medical University Szczecin Academic / other |
| Locations | 1 site (Szczecin, West Pomeranian Voivodeship) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT07308457 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) receiving autologous or allogeneic hematopoietic stem cell transplants who have been free of active infection for at least two weeks and can provide informed consent.
✕Probably not a fit
Patients with ongoing antibiotic therapy (except cotrimoxazole), fever of unknown origin, recent active infection, or other exclusion criteria are not likely to be eligible or to benefit from the monitoring-only strategy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults undergoing autologous or allogeneic hematopoietic stem cell transplantation are randomly assigned to receive either daily ceftriaxone prophylaxis or no preventive antibiotics with intensified monitoring. The monitoring arm uses continuous temperature sensors and frequent microbiological testing, including genetic methods to identify bacteria and resistance markers, with standard antibiotics started if infection signs appear. Researchers will compare rates of infections, bloodstream infections, pneumonia, severe sepsis, antibiotic resistance patterns, blood count recovery, and length of hospital stay. The trial is conducted at a single transplant center and follows participants through the peri-transplant neutropenic period.
Why it matters
Potential benefit: If successful, this approach could let patients avoid routine preventive antibiotics while keeping infection rates low and reducing the development of antibiotic resistance.
How similar studies have gone: Previous trials have shown that antibiotic prophylaxis can reduce some infections during neutropenia but often increases resistance, while intensive microbiological surveillance without routine prophylaxis has been less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Controlled fungal infection. * Fever of unknown origin. * Ongoing antibiotic therapy (except cotrimoxazole). * Participation in any clinical study or experiment at the time of inclusion.
Where it's running
-
Uniwersytecki zpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego Pomorskiego Uniwersytetu Medycznego w Szczecinie
Szczecin, West Pomeranian Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Sławomir Milczarek, MD
- Email: slawomir.milczarek@pum.edu.pl
- Phone: +48 881 241 284
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.