NCT07308457 Enhanced Molecular Microbiological Surveillance Versus Ceftriaxone Prophylaxis in Hematopoietic Cell Transplant Patients
| NCT ID | NCT07308457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pomeranian Medical University Szczecin |
| Condition | Incidence of Infectious Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-09-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07308457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Incidence of Infectious Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07308457 currently recruiting?
Yes, NCT07308457 is actively recruiting participants. Contact the research team at slawomir.milczarek@pum.edu.pl for enrollment information.
Where is the NCT07308457 trial being conducted?
This trial is being conducted at Szczecin, Poland.
Who is sponsoring the NCT07308457 clinical trial?
NCT07308457 is sponsored by Pomeranian Medical University Szczecin. The trial plans to enroll 100 participants.