EUCTR2019-003842-34-GR进行中（未招募）1 期
A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to <2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection - Posaconazole (MK-5592) IV and oral in children (less than 2 years) with IFI
Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc0 个研究点目标入组 40 人开始时间: 2021年5月5日最近更新:
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
- 40
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
- •Panel A Participants Only
- •1. Is undergoing treatment for possible, probable, or proven IFI known or suspected to be caused by fungal pathogens against which POS has demonstrated activity (which can include candidiasis) per the modified EORTC/MSG consensus criteria
- •Panel B Participants Only
- •2. Has a diagnosis of possible, probable, or proven IFI known or suspected to be caused by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis) per the modified 2008 EORTC/MSG consensus criteria
- •3. If enrolled with a possible or probable IFI diagnosis, has one or more of the following host factors as per the modified 2008 EORTC/MSG consensus criteria:
- •- Recent history of neutropenia (<0.5 × 109 neutrophils/L [<500 neutrophils/mm3]) within 30 days before screening
- •- Receipt of an allogeneic HSCT
- •- Prolonged use of corticosteroids for >3 weeks (average minimum dose of 0.3 mg/kg/day of prednisone equivalent)
- •- Treatment with other recognized T-cell immune suppressants, including cyclosporine, TNF-a blockers, specific monoclonal antibodies (such as alemtuzumab), or nucleoside analogues during the past 90 days
- •- Inherited severe immunodeficiency (including but not limited to chronic granulomatous disease or severe combined immunodeficiency)
- •4. If enrolled with a possible or probable IFI diagnosis, meets the following criteria as per the modified 2008 EORTC/MSG consensus criteria:
- •- Possible IFI includes participants with clinical and host factor criteria
- •- Probable IFI includes participants with a host factor, a clinical criterion and a mycological criterion providing evidence of a fungal infection by direct or indirect testing
- •5. If enrolled with a proven IFI diagnosis, sampling of normally sterile tissue has shown fungal elements (by cytology or microscopy), or sampling of normally sterile tissue or blood has yielded a positive culture for a fungal pathogen as per the modified 2008 EORTC/MSG consensus criteria
- •6. Has clinical symptoms consistent with an acute episode of IFI, defined as duration of clinical syndrome of <30 days
- •7. Has a central line (eg, central venous catheter, peripherally inserted central catheter) in place or planned to be in place before beginning IV study intervention
- •8. Is male or female, from birth to <2 years of age at the time of first dose of study intervention
- •9. Has a body weight of =500 g
- •10. The participant (or legally acceptable representative) has provided documented informed consent for the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Panel A and B Participants
- •1. Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
- •2. Has known or suspected active COVID-19 infection
- •3. Has chronic (=30 days' duration) IFI, relapsed/recurrent IFI, or
- •refractory IFI that has not responded to prior antifungal treatment
- •4. Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study
- •intervention used
- •5. Has any known history of torsade de pointes, unstable cardiac
- •arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention
- •6. Has known or suspected Gilbert disease
- •7. Has any condition that, in the opinion of the investigator, may
- •interfere with optimal participation in the study
- •Panel B Participants Only
- •8. Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •9. Has invasive candidiasis.
- •Panel A Participants Only
- •10. Has received any treatment specifically listed in the protocol within the specified time period before the start of study intervention
- •Panel B Participants Only
- •11.Has received any treatment specifically listed in the protocol within the specified time period before the start of study intervention.
- •12.Has enrolled previously in the current study and been discontinued
- •13.Has QTc prolongation (based on either Fridericia or Bazett's correction) at screening >500 msec
- •14.Has significant liver dysfunction at screening, defined as:
- •- Total bilirubin >1.5 × ULN and AST or ALT >3 × ULN with normal alkaline phosphatase
- •15. Has calculated creatinine clearance <20 mL/min/1.73 m2 (modified Schwartz formula) at screening
- •16.Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
- •17.Has an immediate family member (eg, parent/legal guardian, sibling) who is investigational site or Sponsor staff directly involved with this study
研究者
相似试验
招募中
1 期
Posaconazole (MK-5592) IV and oral in children (less than 2 years) with IFIFungal infectionMedDRA version: 20.0Level: LLTClassification code: 10017534Term: Fungal infection NOS Class: 10021881CTIS2023-505613-24-00Merck Sharp & Dohme LLC32
进行中（未招募）
1 期
Posaconazole (MK-5592) IV and oral in children less than 2 years of age with invasive fungal infectioInvasive Fungal InfectionMedDRA version: 20.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2019-003842-34-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc40
招募中
2 期
Posaconazole (MK-5592) IV and oral in children (less than 2 years) with IFIFungal infection2023-505613-24-00Merck Sharp & Dohme LLC13
进行中（未招募）
1 期
Posaconazole (MK-5592) IV and oral in children less than 2 years of age with invasive fungal infectioInvasive Fungal InfectionMedDRA version: 20.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2019-003842-34-Outside-EU/EEAMerck Sharp & Dohme LLC
进行中（未招募）
不适用
An Open-Label, Single-Arm, Multi-Center, Phase 2 Study of Troxatyl troxacitabine Administered by Continuous Infusion in Patients with Acute Myeloid Leukemia AML in Second SalvagePatients with Acute Myeloid Leukemia AML in second salvageMedDRA version: 9.1Level: LLTClassification code 10000880Term: Acute myeloid leukaemiaEUCTR2005-001721-29-ITSTRUCTURAL GENOMIX211