Comparison of Enhanced Molecular-Level Microbiological Surveillance and Ceftriaxone Prophylaxis in Patients Undergoing Hematopoietic Cell Transplantation: A Randomized, Prospective Medical Experiment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of infections in the no-prophylaxis group versus the ceftriaxone prophylaxis group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Controlled fungal infection.
- •Fever of unknown origin.
- •Ongoing antibiotic therapy (except cotrimoxazole).
- •Participation in any clinical study or experiment at the time of inclusion.
研究组 & 干预措施
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.
干预措施: Ceftriaxone 1000 MG (Drug)
结局指标
主要结局
Incidence of infections in the no-prophylaxis group versus the ceftriaxone prophylaxis group
时间窗: 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).
次要结局
- Incidence of infectious complications(From Day -1 until neutrophil recovery or start of empirical antibiotic therapy (up to ~28 days))
- Time to neutrophil recovery(From Day -1 until neutrophil recovery)
- Incidence of infections caused by multidrug-resistant pathogens(From Day -1 until neutrophil recovery or start of empirical antibiotic therapy)
- Time to platelet recovery(From Day -1 until platelet recovery)
- Incidence and severity of acute graft-versus-host disease (GvHD)(Up to Day 100 after transplantation)
- Incidence of organ failure(From Day -1 until neutrophil recovery or start of empirical antibiotic therapy)
- Duration of hospitalization(Through hospital discharge (up to approximately 6 weeks))
- Incidence of death(From Day -1 until neutrophil recovery (or earlier if death occurs))