NL-OMON47081已完成不适用
Imm-f@ct: Characterization of immune mechanisms in measles and other infectious diseases; role of specificities, functions, maintenance and fitness - Imm-f@ct
RIVM0 个研究点目标入组 419 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 419
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •For cases entering the study at time point 1:
- •In order to be eligible to enter the study at time point 1, the following criteria must be met:
- •* A case has a symptomatic viral/bacterial infection that is laboratory confirmed, and the time point of inclusion is within 3 months after diagnosis (*acute phase*)
- •* Willing to adhere to the protocol and perform all planned visits and sample collections
- •* Having given written informed consent themselves and/or through parents or legal representatives ;For cases first entering the study at time point 2:
- •In order to be eligible to enter the study at time point 2, the following criteria must be met:
- •* A case has had a symptomatic viral/bacterial infection that is laboratory confirmed, and the time point of inclusion is around 9 months (± 1 month) after diagnosis or a case has had a symptomatic Bordetella pertussis infection that is laboratory confirmed and the time point of inclusion is around 12 months (± 1 month)
- •* A case does not enter the Periscope pertussis group
- •* Is willing to adhere to the protocol and perform all further planned visits and sample collections
- •* Has given written informed consent him/herself and/or through parents or legal representatives ;For cases first entering the study at time point 3:
- •In order to be eligible to enter the study at time point 3, the following criteria must be met:
- •* A case has had a symptomatic viral/bacterial infection that is laboratory confirmed, and the time point of inclusion is around 18 months (± 2 months) after diagnosis
- •* A case does not enter the Periscope pertussis group
- •* Is willing to adhere to the protocol and perform the further planned visit and sample collection
- •* Has given written informed consent him/herself and/or through parents or legal representatives ;For cases first entering the study at time point 4:
- •In order to be eligible to enter the study at time point 4, the following criteria must be met:
- •* A case has had a viral/bacterial infection that is laboratory confirmed, and the time point of inclusion is around 36 months (± 3 months) after diagnosis
- •* A case does not enter the Periscope pertussis group
- •* Is willing to adhere to the protocol
- •* Has given written informed consent him/herself and/or through parents or legal representatives ;For age-matched controls:
- •* Negative clinical history and absence of a serological response against at least one of the panel of pathogens of interest for this study in the past 12 months.
- •* Having given written informed consent themselves and/or through parents or legal representatives
- •* Having been vaccinated, if applicable according to birth cohort, against measles, Bordetella pertussis, Streptococcus pneumoniae and/or mumps
排除标准
- •* Be or have been under immunosuppressive medical treatment, like cytostatics and prednisolons that might interfere with the results of the study, within the previous 3 months. In exemption to this criterion, short-term (*15 days), systemic immunosuppressive medication is permitted in case this medication is used to treat infections;
- •* Have any known primary or secondary immunodeficiency;
- •* Have a bleeding disorder or be under treatment with anticoagulants. In case of use of anti-coagulants, adult volunteers can be included if no spontaneous bleedings occurred in the month prior to venipuncture, if the dose of medication is stable (no changes in the month prior to venipuncture) and/or INR testing is performed at * 2 times a month, and if the INR value is below 3.5 (based on the information provided by the volunteer).;A control is not eligible when he/she reports to
- •* Have developed clinical symptoms of a virus or pathogen infection in the very short period of time between the identification as a control and the date of the home visit.
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