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

NCT ID: NCT07308457

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-10-31

Brief 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.

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.

Conditions

Incidence of Infectious Diseases

Keywords

Hematopoietic Cell Transplantation; Bloodstream Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ceftriaxone Prophylaxis

Participants assigned to this arm will receive prophylactic ceftriaxone 1 g intravenously once daily, administered at a fixed morning time, starting 24 hours before hematopoietic stem cell infusion (Day -1) and continued until neutrophil recovery or the onset of infection symptoms. All participants undergo continuous body temperature monitoring and standardized microbiological diagnostics in case of fever or suspected infection.

Group Type: EXPERIMENTAL

Ceftriaxone 1000 MG

Intervention Type: DRUG

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.

No Prophylaxis

Participants in this arm will not receive prophylactic antibacterial therapy. They will undergo the same continuous body temperature monitoring as the intervention group. In case of fever or other indicators of infection, full microbiological diagnostics will be initiated and empirical antibiotic therapy will be started according to clinical judgment and local epidemiology.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pomeranian Medical University Szczecin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Szczecin, West Pomeranian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Sławomir Milczarek, MD

Role: CONTACT

Phone: +48 881 241 284

Email: slawomir.milczarek@pum.edu.pl

Facility Contacts

Karolina Sorbian-Gajewska

Role: primary

Other Identifiers

CRONOS

Identifier Type: -

Identifier Source: org_study_id