EUCTR2018-001344-57-IT进行中（未招募）1 期
Pentaglobin as early adjuvant treatment for febrile neutropenia in acute leukemia or allogeneic hematopoietic stem cell transplant patients colonized by carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa - PENTALLO
GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA0 个研究点目标入组 120 人开始时间: 2021年6月17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
- 120
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
- •Age > or = 18 years
- •Performance status: ECOG <3
- •Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia candidate to intensive chemotherapy or Indication to allogeneic Hematopoietic stem cell transplantation (HSCT) for hematological cancers, including severe aplastic anemia (second transplants allowed)
- •Pre-treatment colonization by Carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) documented by rectal and/or pharyngeal swab or pre-treatment bloodstream infection sustained by CRE or PA
- •Written and signed informed consent
- •Patients participating in other clinical studies for allogeneic HSCT are also eligible to this study if the above-mentioned trials are using an approved investigational compound
- •Possibility of starting treatment with Pentaglobin <12 hours after development of fever
- •Treatment with other immunoglobulins (e.g. IVIG, Cytotect) should be not administered during the time of treatment with Pentaglobin.
- •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 10
排除标准
- •Uncontrolled systemic infection
- •-Hypersensitivity to the active substance or to any of the excipients of Pentaglobin
- •Patients with previous anaphylaxis or severe reactions to immunoglobulins preparation
- •Severe concomitant illness:
- •opatients with severe renal impairment
- •opatients with severe pulmonary impairment
- •opatients with severe cardiac impairment
- •opatients with severe hepatic impairment
- •patients who on the basis of the investigator's consideration are not able to give the informed consent.
研究者
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