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

NCT07308457 | Recruiting

• 1 other identifier: CRONOS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Incidence of Infectious Diseases

Keywords

Hematopoietic Cell Transplantation; Bloodstream Infections

Outcome Measures

Primary Outcomes (1)

• Incidence of infections in the no-prophylaxis group versus the ceftriaxone prophylaxis group

  The primary outcome is the proportion of patients who develop an infection in the group receiving no antibacterial prophylaxis compared with the group receiving prophylactic ceftriaxone 1 g once daily. Infection is defined in the protocol as the occurrence of: neutropenic fever (single temperature \>38.3°C or ≥38.0°C for ≥1 hour with ANC \<500/µl or anticipated decline to \<500/µl within 48 hours); bloodstream infection/bacteremia confirmed by blood culture; sepsis or septic shock; or clinically/microbiologically confirmed localized infection (respiratory, urinary, gastrointestinal, or other site). Assessment continues until neutrophil recovery (\>500/µl for 3 consecutive days).

  From Day -1 (24h before transplant) until neutrophil recovery (>500/µl for 3 consecutive days)

Secondary Outcomes (8)

• Incidence of infectious complications

  From Day -1 until neutrophil recovery or start of empirical antibiotic therapy (up to ~28 days)

• Incidence of infections caused by multidrug-resistant pathogens

  From Day -1 until neutrophil recovery or start of empirical antibiotic therapy

• Incidence of organ failure

  From Day -1 until neutrophil recovery or start of empirical antibiotic therapy

• Incidence of death

  From Day -1 until neutrophil recovery (or earlier if death occurs)

• Time to neutrophil recovery

  From Day -1 until neutrophil recovery

Study Arms (2)

Ceftriaxone Prophylaxis

EXPERIMENTAL

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.

Drug: Ceftriaxone 1000 MG

No Prophylaxis

NO INTERVENTION

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.

Interventions

Ceftriaxone 1000 MG 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.

Ceftriaxone Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Controlled fungal infection.
• Fever of unknown origin.
• Ongoing antibiotic therapy (except cotrimoxazole).

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

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

Szczecin, West Pomeranian Voivodeship, 71-252, Poland

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Sławomir Milczarek, MD

CONTACT

+48 881 241 284; slawomir.milczarek@pum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 29, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

PL (1)