2022-500389-84-00招募中4 期
SAFE study: Stopping Antibiotics after 3 days for the treatment of FEbrile Neutropenia in Haematology patients, a randomized open-label non-inferiority trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 410
- 试验地点
- 9
- 主要终点
- Absence of a serious medical complication (SMC) following 42 days after randomisation. SMC is defined as: Death; and/or ICU admission; and/or Septic shock requiring vasopressive therapy.
研究概览
简要总结
To assess if a strategy of short antibiotic treatment (72h) with a broad-spectrum antibiotic is as safe as extended treatment of high-risk febrile neutropenia in hematology patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Age older than 16 years
- •Intensive therapy is started within three days before randomization for one of the following haematological conditions: Remission induction chemotherapy for newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS); OR Re-induction chemotherapy for relapsed after haematological remission lasting for a minimum duration of 6 months; OR Conditioning regimen to prepare for an allogeneic HCT; OR Conditioning regimen to prepare for an autologous HCT.
- •Expected longstanding (≥ 7 days) neutropenia (absolute neutrophil count < 0.5x10^9/L)
- •Expected length of hospital stay of at least 10 days
排除标准
- •Clinically or microbiologically documented infection
- •Patient already receives broad spectrum antibiotic therapy
- •Any critical illness for which Intensive Care Unit treatment is required
- •SOFA score ≥ 11
- •Longstanding neutropenia (>21 days) prior inclusion
- •Previous enrolment in this study
- •Not able to provide written informed consent
- •Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
结局指标
主要结局
Absence of a serious medical complication (SMC) following 42 days after randomisation. SMC is defined as: Death; and/or ICU admission; and/or Septic shock requiring vasopressive therapy.
Absence of a serious medical complication (SMC) following 42 days after randomisation. SMC is defined as: Death; and/or ICU admission; and/or Septic shock requiring vasopressive therapy.
次要结局
- Incidence of bacteraemia within 42 days after randomisation
- Clinically documented infections
- Number of documented bacterial infections
- Total days of non-prophylactic antibiotics given to the patient at engraftment
- Total numbers of antibiotic switches before neutrophil recovery
- Incidence of Clostridium difficile infection
- Incidence, severity and duration of diarrhea
- Incidence of candidemia
- Length of hospital stay in the first 42 days after randomization
- Number of patients admitted to the ICU within 42 days after randomisation
- Number of readmissions within 42 days
- Number of patients with a culture (surveillance or diagnostic culture) positive for resistant bacteria: VRE; ESBL; MRSA; and/or CPE
- Duration of hospitalization
- Number of patients in the short treatment arm with ongoing fever at time of EBAT stop
- Incidence of acute GVHD (grade II or higher) in the transplanted study population
研究者
Robina Aerts
Scientific
UZ Leuven
研究点 (9)
Loading locations...
相似试验
招募中
3 期
Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteremia (SAFE-trial)2024-515398-90-01Stichting Amsterdam UMC300
招募中
4 期
Efficacy and safety of 7 versus 14 days of antibiotic treatment for bacteremia produced by Pseudomonas aeruginosa: a multicenter, randomized (SHORTEN-2) clinical trial with a DOOR/RADAR analysis.2023-508441-41-00Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla306
招募中
4 期
Efficacy of 7 days versus 14 days of antibiotic therapy for acute pyelonephritis in kidney transplant recipientsPyelonephritis2024-513328-40-00Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris470
招募中
4 期
The effect of different antibiotic protocols for dental implant surgery on peri-implant tissue health and on oral microbiome and resistome2023-510391-31-00Universita Degli Studi Di Genova80
招募中
4 期
Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia:
A randomized, non-blinded, non-inferiority interventional study (SAB 7)2024-519186-21-01Hvidovre Hospital264