Incidence of Infectious DiseasesCRONOSNCT07308457
Enhanced Molecular Microbiological Surveillance Versus Ceftriaxone Prophylaxis in Hematopoietic Cell Transplant Patients
A study testing Ceftriaxone 1000 MG in people with Incidence of Infectious Diseases, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incidence of Infectious Diseases
- What is being tested?
- Ceftriaxone 1000 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Controlled fungal infection.
- Fever of unknown origin.
- Ongoing antibiotic therapy (except cotrimoxazole).
- Participation in any clinical study or experiment at the time of inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Uniwersytecki zpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego Pomorskiego Uniwersytetu Medycznego w Szczecinie
Szczecin, West Pomeranian Voivodeship, 71-252
Karolina Sorbian-Gajewska, 505303518, karolina.sorbian.gajewska@pum.edu.pl
Sławomir Milczarek, MD
About this study
Official title: Comparison of Enhanced Molecular-Level Microbiological Surveillance and Ceftriaxone Prophylaxis in Patients Undergoing Hematopoietic Cell Transplantation: A Randomized, Prospective Medical Experiment
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:
Read more
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.
Read the 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
- Being tested
- Ceftriaxone 1000 MG
- Keywords
- Hematopoietic Cell Transplantation, Bloodstream Infections
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone 1000 MGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Day -1 (24h before transplant) until neutrophil recovery (>500/µl for 3 consecutive days)
Secondary outcomes (8)
Incidence of infectious complications
Proportion of patients experiencing infectious complications defined in the protocol as: neutropenic fever, sepsis, septic shock, pneumonia, sinus infection, urinary tract infection, and gastrointestinal infection. Neutropenic fever is defined as a single temperature >38.3°C or temperature ≥38.0°C for at least one hour with ANC <500/µl or expected decline to <500/µl within 48 hours. Bloodstream infection/bacteremia refers to growth of a microorganism in blood culture with exclusion of contamination. Sepsis and septic shock are defined according to protocol criteria.
Measured: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy (up to ~28 days)
Incidence of infections caused by multidrug-resistant pathogens
Proportion of patients with infections caused by multidrug-resistant pathogens, as determined by microbiological and molecular diagnostics performed at the onset of infection.
Measured: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy
Incidence of organ failure
Proportion of patients who develop organ failure, defined in the protocol as:
- Respiratory failure: PaO₂ <60 mmHg or PaCO₂ ≥45 mmHg.
- Circulatory failure: need for vasopressors or inotropes and fluid therapy to maintain systolic blood pressure ≥90 mmHg.
- Renal failure: acute kidney injury defined as increase in serum creatinine ≥0.3 mg/dl within 48 hours, or ≥1.5-fold increase within 7 days, or urine output <0.5 ml/kg/h for 6 hours.
- Liver failure: acute hepatic failure <26 weeks with encephalopathy and INR ≥1.5.
Measured: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy
Incidence of death
Proportion of patients who die during the study period in the prophylactic ceftriaxone group compared with the no-prophylaxis group.
Measured: From Day -1 until neutrophil recovery (or earlier if death occurs)
Time to neutrophil recovery
Time from Day -1 to achievement of neutrophil recovery, defined as three consecutive days with ANC >500/µl.
Measured: From Day -1 until neutrophil recovery
Time to platelet recovery
Time to achievement of platelet recovery, defined as three consecutive days with platelet count >20,000/µl without platelet transfusions.
Measured: From Day -1 until platelet recovery
Duration of hospitalization
Total number of days of hospitalization during the transplant period for each participant.
Measured: Through hospital discharge (up to approximately 6 weeks)
Incidence and severity of acute graft-versus-host disease (GvHD)
Proportion of patients who develop acute GvHD and its severity, assessed according to MAGIC criteria. Acute GvHD involves skin, liver, and gastrointestinal tract and is evaluated up to Day 100 after transplantation.
Measured: Up to Day 100 after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308457
- Sponsor's protocol ID
- CRONOS
- Acronym
- CRONOS
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Enhanced Molecular-Level Microbiological Surveillance and Ceftriaxone Prophylaxis in Patients Undergoing Hematopoietic Cell Transplantation: A Randomized, Prospective Medical Experiment
- ClinicalTrials.gov ID
- NCT07308457
- Acronym / sponsor ID
- CRONOS / CRONOS
- Conditions
- Incidence of Infectious Diseases
- Keywords
- Hematopoietic Cell Transplantation, Bloodstream Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone Prophylaxis | Experimental | Drug: Ceftriaxone 1000 MGParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Controlled fungal infection.
- Fever of unknown origin.
- Ongoing antibiotic therapy (except cotrimoxazole).
- Participation in any clinical study or experiment at the time of inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftriaxone 1000 MGParticipants 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. | Drug | Ceftriaxone Prophylaxis |
Primary outcome
Incidence of infections in the no-prophylaxis group versus the ceftriaxone prophylaxis group
Time frame: From Day -1 (24h before transplant) until neutrophil recovery (>500/µl for 3 consecutive days)
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).
8 secondary outcomes
Incidence of infectious complications
Time frame: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy (up to ~28 days)
Incidence of infections caused by multidrug-resistant pathogens
Time frame: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy
Incidence of organ failure
Time frame: From Day -1 until neutrophil recovery or start of empirical antibiotic therapy
Incidence of death
Time frame: From Day -1 until neutrophil recovery (or earlier if death occurs)
Time to neutrophil recovery
Time frame: From Day -1 until neutrophil recovery
Time to platelet recovery
Time frame: From Day -1 until platelet recovery
Duration of hospitalization
Time frame: Through hospital discharge (up to approximately 6 weeks)
Incidence and severity of acute graft-versus-host disease (GvHD)
Time frame: Up to Day 100 after transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceftriaxone 1000 MG in people with Incidence of Infectious Diseases, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sławomir Milczarek, MD (+48 881 241 284, slawomir.milczarek@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infections in the no-prophylaxis group versus the ceftriaxone prophylaxis group (time frame: From Day -1 (24h before transplant) until neutrophil recovery (>500/µl for 3 consecutive days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.