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.
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.
Controlled fungal infection.
Fever of unknown origin.
Ongoing antibiotic therapy (except cotrimoxazole).
Participation in any clinical study or experiment at the time of inclusion.
Parallel
Ceftriaxone 1000 MG
DrugParticipants 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.
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).
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.
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.
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.
Incidence of death
Proportion of patients who die during the study period in the prophylactic ceftriaxone group compared with the no-prophylaxis group.
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