Prospective Unblinded Randomized Trial to Examine Short vs Prolonged Antibiotic Treatment for Hospitalized Hemato-oncology Patients With Febrile Neutropenia
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- A successful response to treatment
研究概览
简要总结
Neutropenic fever is a life threatening condition that is not rare in patients suffering from hematologic disorders, and of paramount importance to early and effective treatment. In this trial we concentrate on hospitalized patients with hematologic malignancies who develop neutropenic fever.
In recent years, several studies were conducted to examine possible changes in the conventional empirical treatment, assuming that administration of the antibiotics in a prolonged infusion would allow for a greater fT > MIC that will lead to a better efficacy.
These studies were carried out in different populations and there is only limited information about the importance of continuous infusion therapy in patients with hematologic diseases with neutropenic fever.
Research goals: The main goal is to compare between two groups of hematologic patients with neutropenic fever, The first group will receive antibiotic therapy in extended infusion, and the second (control) group will receive the treatment in a fixed time.
详细描述
METHODS: Each patient who will be hospitalized in the Department of Bone Marrow Transplantation and which meets the Inclusion criteria for, will be offered to participate in the study. If fever appears during hospitalization empirical treatment of neutropenia will be initiated performed in accordance with the allocation of the patient in the study. Therapeutic success is defined as a combination of several clinical parameters, including: a decline in Fever, the recurrence of fever and improvement in infection.
METHODS: Study format - Prospective unblinded randomized trial.
Neutropenic fever measurement will be set above the fold of 38.3 ° C or fever over 38.0 ° C lasting more than an hour. Neutropenia is defined as absolute neutrophil count (ANC) less than 500 cells / mm3, or expected to fall below this value for the next 48 hours.
Primary care would be one of three options:
- Tazocin: 4.5gr, TID, I.V. Or
- Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients. Or
- Meropenem: 1.0gr, TID, I.V. - In cases of hypotension not responding to fluids resuscitation, and in consultation with the infectious diseases unit - we will start empirical treatment with Meropenem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are able to sign an informed consent form
- •Hospitalized patients for one of the following reasons:
- •Induction or consolidation for Acute Leukemia
- •Patients Hospitalized for Autologous BMT
- •Patients Hospitalized for Allogeneic BMT.
排除标准
- •Patients under the age of
- •Patients who are unable to provide informed consent.
- •Patients with acute lymphatic leukemia hospitalized for maintenance treatment
- •Patients who will not be staying for the entire duration of neutropenia in house.
研究组 & 干预措施
Prolonged Infusion of antibiotics
Prolonged (4 hours) Infusion of antibiotics.
Intervention:
Primary care would be one of three options:
- Piperacillin/tazobactam : 4.5gr, TID, I.V.
Or 2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.
Or 3. Meropenem: 1.0gr, TID, I.V.
Supplementation of Vancomycin will be at the discretion of the treating physician.
干预措施: Piperacillin/tazobactam (Drug)
Prolonged Infusion of antibiotics
Prolonged (4 hours) Infusion of antibiotics.
Intervention:
Primary care would be one of three options:
- Piperacillin/tazobactam : 4.5gr, TID, I.V.
Or 2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.
Or 3. Meropenem: 1.0gr, TID, I.V.
Supplementation of Vancomycin will be at the discretion of the treating physician.
干预措施: Ceftazidim (Drug)
Prolonged Infusion of antibiotics
Prolonged (4 hours) Infusion of antibiotics.
Intervention:
Primary care would be one of three options:
- Piperacillin/tazobactam : 4.5gr, TID, I.V.
Or 2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.
Or 3. Meropenem: 1.0gr, TID, I.V.
Supplementation of Vancomycin will be at the discretion of the treating physician.
干预措施: Meropenem (Drug)
Prolonged Infusion of antibiotics
Prolonged (4 hours) Infusion of antibiotics.
Intervention:
Primary care would be one of three options:
- Piperacillin/tazobactam : 4.5gr, TID, I.V.
Or 2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.
Or 3. Meropenem: 1.0gr, TID, I.V.
Supplementation of Vancomycin will be at the discretion of the treating physician.
干预措施: Vancomycin (Drug)
Fixed time infusion of antibiotics
Fixed time (half and hour) infusion of antibiotics.
Intervention:
Primary care would be one of three options:
- Piperacillin/tazobactam : 4.5gr, TID, I.V.
Or 2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.
Or 3. Meropenem: 1.0gr, TID, I.V.
Supplementation of Vancomycin will be at the discretion of the treating physician/
干预措施: Piperacillin/tazobactam (Drug)
Fixed time infusion of antibiotics
Fixed time (half and hour) infusion of antibiotics.
Intervention:
Primary care would be one of three options:
- Piperacillin/tazobactam : 4.5gr, TID, I.V.
Or 2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.
Or 3. Meropenem: 1.0gr, TID, I.V.
Supplementation of Vancomycin will be at the discretion of the treating physician/
干预措施: Ceftazidim (Drug)
Fixed time infusion of antibiotics
Fixed time (half and hour) infusion of antibiotics.
Intervention:
Primary care would be one of three options:
- Piperacillin/tazobactam : 4.5gr, TID, I.V.
Or 2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.
Or 3. Meropenem: 1.0gr, TID, I.V.
Supplementation of Vancomycin will be at the discretion of the treating physician/
干预措施: Meropenem (Drug)
Fixed time infusion of antibiotics
Fixed time (half and hour) infusion of antibiotics.
Intervention:
Primary care would be one of three options:
- Piperacillin/tazobactam : 4.5gr, TID, I.V.
Or 2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.
Or 3. Meropenem: 1.0gr, TID, I.V.
Supplementation of Vancomycin will be at the discretion of the treating physician/
干预措施: Vancomycin (Drug)
结局指标
主要结局
A successful response to treatment
时间窗: Interim analysis is planed after 1 year , when a recruitment of 50 patients is expected
A successful response to treatment will be defined by a combination of all the following: A. A defervescence of fever for at least 48 hours. B. Disappearance or improvement of clinical signs and symptoms of infection. C. No: bacteremia / re-emergence of fever / signs of infection within 5 days from starting of treatment.
次要结局
- Duration of Hospitalization(For the duration of hospital stay - an expected average of 4 weeks)
- Number of days of Neutropenia(For the duration of hospital stay - an expected average of 4 weeks)
- Any systemic organ Failure (Renal / Hepatic / Cardio or pulmonary)(For the duration of hospital stay - an expected average of 4 weeks)
- Breakthrough fever or Additional bacteremia(5 days after primary treatment)
- Clostridium difficile infection(For the duration of hospital stay - an expected average of 4 weeks)
- Survival(During 30 days from begining of treatment)
研究者
michal roll
Director of R & D - Tel Aviv Sourasky M C
Tel-Aviv Sourasky Medical Center