Enhanced Molecular Microbiological Surveillance Versus Ceftriaxone Prophylaxis in Hematopoietic Cell Transplant Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPomeranian Medical University Szczecin

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Controlled fungal infection.

Fever of unknown origin.

Ongoing antibiotic therapy (except cotrimoxazole).

Participation in any clinical study or experiment at the time of inclusion.

Trial design

Treatments tested in this trial

  • Ceftriaxone 1000 MG

Treatment groups

100 Participants
are divided into 2 treatment groups