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

Official title

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

Overview

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.

Detailed description

This study compares two common strategies for preventing infections in adults who receive hematopoietic stem cell transplants (HSCT). People who undergo these transplants often have very low levels of white blood cells for several days or weeks. During this time, they have a high risk of developing serious infections. Many hospitals give preventive antibiotics, but increasing resistance to these drugs has raised questions about whether this approach is still effective.

In this study, participants are randomly assigned to one of two groups. One group receives daily ceftriaxone as preventive treatment. The other group does not receive preventive antibiotics and instead is closely monitored using continuous temperature sensors and frequent microbiological testing. If any participant shows signs of infection, the medical team begins standard antibiotic treatment based on the person's symptoms, test results, and the hospital's local patterns of bacterial resistance.

The study uses modern laboratory methods, including genetic tests to identify bacteria and antibiotic resistance markers. These tests are performed when a participant develops fever or other symptoms of infection. Researchers will track how often infections occur, how severe they are, and whether bacteria are resistant to antibiotics. They will also monitor recovery of blood counts, the length of hospital stay, and whether participants develop complications related to the transplant.

The results of this study may help hospitals choose the safest and most effective approach to preventing infections in transplant patients, especially in settings where resistance to commonly used antibiotics is increasing.

Interventions

• Drug Ceftriaxone 1000 MG
  Participants in this arm receive prophylactic ceftriaxone administered intravenously at a dose of 1 g once daily. The infusion begins on Day -1 (24 hours before hematopoietic stem cell infusion) and continues until neutrophil recovery (ANC \>500/µl for 3 consecutive days) or until signs of infection occur. Ceftriaxone is infused over at least 30 minutes after dissolving 1 g of the drug in 20-40 ml of an intravenous solution that does not contain calcium ions (e.g., 0.9% sodium chloride, 5% gluco

Primary outcome measures

• Incidence of infections in the no-prophylaxis group versus the ceftriaxone prophylaxis group [Time frame: From Day -1 (24h before transplant) until neutrophil recovery (>500/µl for 3 consecutive days)]

Secondary outcome measures (8)

• Incidence of infectious complications [Time frame: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy (up to ~28 days)]
• Incidence of infections caused by multidrug-resistant pathogens [Time frame: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy]
• Incidence of organ failure [Time frame: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy]
• Incidence of death [Time frame: From Day -1 until neutrophil recovery (or earlier if death occurs)]
• Time to neutrophil recovery [Time frame: From Day -1 until neutrophil recovery]
• Time to platelet recovery [Time frame: From Day -1 until platelet recovery]
• Duration of hospitalization [Time frame: Through hospital discharge (up to approximately 6 weeks)]
• Incidence and severity of acute graft-versus-host disease (GvHD) [Time frame: Up to Day 100 after transplantation]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Poland · 1 center

• Uniwersytecki zpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego Pomorskiego Uniwersyt — Szczecin

Identifiers

NCT: NCT07308457 · CRONOS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗