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RECRUITING
NCT07308457
NA

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

Sponsor: Pomeranian Medical University Szczecin

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-09-01

Completion Date

2027-10-31

Last Updated

2025-12-29

Healthy Volunteers

No

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% glucose, 10% glucose, or other compatible diluents specified in the protocol). Continuous real-time temperature monitoring is performed throughout the intervention period.

Locations (1)

Uniwersytecki zpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego Pomorskiego Uniwersytetu Medycznego w Szczecinie

Szczecin, West Pomeranian Voivodeship, Poland