A Phase-IIa, Double-blind, Randomized Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Proven Candidaemia. (SLIC: Study of Lactoferrin Peptide in Infections With Candida)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.
研究概览
简要总结
This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection.
详细描述
RATIONALE FOR THE STUDY
Choice of Drug
Fluconazole is considered "standard care" for the treatment of Candida infections, including candidaemia in hospitalized patients.
Preclinical data has demonstrated that hLF1-11 possesses potent antimycotic effects against Candida sp and, importantly, to be synergistic with fluconazole, whereby Candida strains that are fluconazole-resistant become sensitive through the addition of hLF1-11
Choice of Patient Population
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before admission in the study.
- •Patients in whom Candida species have been confirmed by 2 consecutive blood cultures within 12 hours.
- •Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 hours prior to entry.
- •Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.
排除标准
- •Patients with a history of hypersensitivity to fluconazole or hLF1-
- •Patients who have been treated with fluconazole for at least 1 week within the previous 4 weeks.
- •Patients with a history of fluconazole-resistant Candida species within 12 weeks.
- •Neutropenic patients with neutrophil count below 0.5x10^9/L.
- •Patients who are treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole.
- •Patients known to have AIDS or who are HIV-positive.
- •Females who have a positive pregnancy test at baseline or are capable of child-bearing i.e. without appropriate contraception (chemical or mechanical).
- •Patients with suspected candida osteomyelitis, endocarditis, or meningitis.
- •Patients who have received an investigational drug within three months prior to the study.
- •Patients with a concomitant medical condition, in whom, in the opinion of the Investigator, participation may create an unacceptable risk for the patient.
- •Patients considered inappropriate by the PI for enrollment in the study, for any reason.
研究组 & 干预措施
hLF1-11
hLF1-11 0.5mg
干预措施: hLF1-11 (Drug)
Placebo
Placebo formulation is Similar to hLF1-11 iv formulation except for the active component
干预措施: Placebo (Drug)
结局指标
主要结局
Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.
时间窗: 28 Days
次要结局
- Test of Cure (TOC): Clinical: complete resolution of clinical signs and symptoms or resolution to a point where no further antifungal therapy is judged necessary; and Microbiological: eradication of Candida identified at baseline.(28 Days)