NL-OMON52806招募中2 期
Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia - rIFN-Gamma 1b in Candidemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Males or non-pregnant females (who must agree to use barrier methods of
- •contraception during the study therapy period, women of childbearing age must
- •have a negative urine pregnancy or serum test at baseline).
- •Subjects who are 18 years of age or older.
- •Subjects with at least one positive blood culture isolation of Candida species
- •from a specimen drawn within 120 hours prior to study entry.
- •Subjects who have clinical evidence of infection sometime within 120 hours
- •prior to enrolment, including at least one of the following:
- •-Temperature >37.8 *C on two occasions at least four hours apart or one
- •measurement > 38.2 *C
- •-Systolic blood pressure <90 or a >30 mmHg decrease in systolic blood pressure
- •from the subject's normal baseline or the need for vassopressive therapy.
- •-Signs of inflammation (swelling, heat, erythema, purulent drainage) from a
- •site infected with Candida (e.g. joint, skin, eye, bone, oesophagus).
- •-Radiologic findings of invasive candidiasis.
- •Subject or their legal representative must sign a written informed consent form.
- •- In case a patient eligible to participate in this study is incapacitated and
- •as such unable to personally provide informed consent, a written consent form
- •must be signed by their legal representative.
- •- Only incapacitated patients that can be expected to regain the capability to
- •consent will be included in this study. In this case, informed consent will be
- •discussed personally with the study participant after recovery.
- •- The inclusion of incapacitated subjects will only be performed under the
- •above conditions in a country in which such an approach is legal and deemed
- •ethically acceptable.
排除标准
- •Subjects with a history of allergy or intolerance to rIFN-γ or any other IMP
- •ingredient or with a history of immediate type hypersensitivity to latex/rubber.
- •Subjects with a history of documented epileptic seizures.
- •Subjects with severe liver failure (>5x upper limit AST or ALT or impaired
- •synthesis of proteins such as coagulation factors manifested by increased
- •prothrombin time).
- •Treatment with heterologous serum proteins, or immunological preparations such
- •as vaccines, toxins, serums and allergens within three days before trial
- •Women who are pregnant or lactating.
- •Subjects who are unlikely to survive more than 24 hours.
- •Subjects who have failed previous systemic antifungal therapy for the Candida
- •spp. infection which is being studied.
- •Subjects who have received more than 120 hours of systemic antifungal therapy
- •for the current episode, within 120 hours prior to study entry.
- •With respect to incapacitated subjects:
- •- Any patient that is deemed incapable of personally providing informed consent
- •due to a neurodegenerative disease, genetic syndrome, and/or perinatal
- •asphyxia, will not be eligible for inclusion in this trial.
- •- Any incapacitated subject that is not expected to recover to a point where
- •they will personally be able to provide informed consent will not be eligible
- •for inclusion in this trial.
研究者
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