EUCTR2017-001056-55-BE进行中（未招募）1 期
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL STUDY OF THE EFFICACY OF INTRAVENOUS CLARITHROMYCIN AS ADJUNCTIVE TREATMENT IN PATIENTS WITH SEPSIS AND RESPIRATORY AND MULTIPLE ORGAN DYSFUNCTION SYNDROME: THE INCLASS STUDY - INTRAVENOUS CLARITHROMYCIN IN SEPSIS AND MULTIPLE ORGAN DYSFUNCTION SYNDROME
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
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
入选标准
- •1.Adult patients (=18 years old)
- •2.Patients of both genders
- •3.Informed consent form signed by patient or by first-degree relative in case of patient unable to consent
- •4.Negative (blood or urinary) pregnancy test for female patients of reproductive age
- •5.Willingness to receive contraception during and seven days after the administration of the study drug.
- •6.Presence of one or more of the following infections: hospital-acquired pneumonia (HAP), health-care associated pneumonia (HCAP), ventilator-associated pneumonia (VAP), primary Gram-negative bacteremia and intra-abdominal infections. Definitions for these infections are given below.
- •7.Presence of sepsis as defined by the Sepsis-3 classification criteria3
- •8.Respiratory dysfunction defined as one PaO2/FiO2 ratio below 200
- •9.Total SOFA points for organ dysfunctions other than the respiratory function more than 3.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1.Denial for informed consent
- •2.Age inferior to 18 years
- •3.Pregnancy (confirmed by blood or urinary pregnancy test) or lactation for female patients of reproductive age.
- •4.Unwillingness to receive contraception during and seven days after the administration of the study drug.
- •5.HIV infection (with known CD4 cell count = 200/mm3)
- •6.Solid organ, or bone marrow transplantation
- •7.Corticosteroid oral or intravenous intake greater than 0.4 mg/kg of equivalent prednisone daily over the last 15 days
- •8.Known active neoplasms compromising short-term survival (1 month)
- •9.Neutropenia <1000/mm3
- •10.Known allergy to macrolides
- •11.Previous participation in the study
- •12.Administration of a macrolide for the current infection
研究者
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