EUCTR2021-000354-25-ES进行中（未招募）1 期
A multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients: efficacy and microbiologic safety. - FOVOCIP
FINBA0 个研究点目标入组 156 人开始时间: 2021年8月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria:
- •1. Subjects must be able to understand the study procedures, comply with them, and give written informed consent prior to any specific study procedure.
- •2. Adult subjects = 18 years of age with a diagnosis of acute leukemia who are to receive their first course of chemotherapy or adult subjects = 18 years of age who are candidates for a first stem cell transplant.
- •3. Expected neutropenia of 100x109/L lasting at least seven days. In the case of an expected range of 100-500x109/L neutropenia lasting seven days or longer, at least one of the following risk factors for infection must be present:
- •a. Performance status (Eastern Cooperative Oncology Group, ECOG) =2.
- •b. Expected grade 3-4 mucositis.
- •c. Age =65 years.
- •d. Comorbidity index (HCTI) =3.
- •e. Serum albumin< 35 g/L.
- •f. Total dose of etoposide > 500 mg/m2.
- •g. Total dose of cytarabine > 1 g/m2.
- •h. Active or refractory neoplasia at the time of stem cell transplantation.
- •4. Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.
- •5. Adequate organ function defined as:
- •- Liver : bilirubin, alkaline phosphatase or SGOT < 3 times the upper limit of normal (unless attributable to tumor activity).
- •- Renal : creatinine = 250 µmol/l (2.5 mg/dL) (unless attributable to AML activity).
- •6. Life expectancy greater than 3 months.
- •7. Women of childbearing age should not be pregnant or breastfeeding and should have a negative pregnancy test at the time of screening. Women of childbearing age and men with female partners of childbearing age must agree to practice 2 highly effective contraceptive measures and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completion of treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •Patients who meet any of the following exclusion criteria cannot be included in this study:
- •1. Hypersensitivity to fluoroquinolones or fosfomycin.
- •2. Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.
- •3. Prior intensive chemotherapy or stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is allowed.
- •4. Fever of infectious origin or documented infection within 4 weeks of first study treatment.
- •5. Presence of any serious psychiatric illness or physical condition that, in the judgment of the physicians, contraindicates the patient's inclusion in the clinical trial.
研究者
相似试验
进行中（未招募）
不适用
Randomized controlled trial of the efficacy of fosfomycin vs ciprofloxacin as antibiotic prophylaxis before transrectal ultrasound guided prostateurinary sepsisEUCTR2012-001031-31-ESFundación para Formación e Investigación Sanitaria
未知
不适用
Multicentre randomized controlled trial on the effects of a preventive intervention of postpartum interpersonal relationships disorder (PIRD)PregnantJPRN-UMIN000019064Kitamura Institute of Mental Health Tokyo400
已完成
3 期
Multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for tod-dlers and preschool children with Autism Spectrum Disorder – A-FFIPDSM-5: 299.0 Autism Spectrum DisorderF84.0F84.5Childhood autismAsperger syndromeDRKS00016330Goethe Universität Frankfurt am Main134
进行中（未招募）
1 期
A multicenter randomised study comparing the efficacy of pegylated interferon-alfa-2a plus placebo vs. pegylated interfeorn-alfa-2a plus tenofovir for the treatment of chronic delta hepatitis- The Hep-Net International Delta hepatits Interventional Trial II (HIDIT-II) - HIDIT-IITo compare the virological efficacy (HDV-RNA) and safety of 96 weeks of therapy with pegylated interferon-alfa-2a plus tenovofir to 96 weeks of therapy with pegylated interferon-alfa-2a plus placebo for the treatment with chronic delta hepatits virus.MedDRA version: 9.1Level: LLTClassification code 10047455Term: Viral hepatitis B without mention of hepatic coma, with hepatitis deltaEUCTR2008-005560-13-GRMedizinische Hochschule Hannover70
已完成
不适用
A multicenter randomised study comparing the efficacy of adefovir dipivoxil versus pegylated interferon alpha-2a plus placebo versus adefovir dipivoxil plus peglyated interferon alpha-2a for the treatment of chronic delta hepatitisAdults with chronic delta hepatitisInfections and InfestationsISRCTN83587695Hannover Medical School (MHH) (Germany)69