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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Recipient of autologous or allogeneic hematopoietic stem cells from peripheral blood, bone marrow, or cord blood. - Age ≥18 years. - Ability to provide written willing to sign a consent form. - No active infection for at least 2 weeks prior to transplantation. Who Should NOT Join This Trial: - Controlled fungal infection. - Fever of unknown origin. - Ongoing antibiotic therapy (except cotrimoxazole). - Participation in any clinical study or experiment at the time of inclusion. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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