Longitudinal Observational Study of the Natural History of Andes Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Time to first virologic detection (X0/E0→P0)
研究概览
简要总结
This is a longitudinal observational cohort study enrolling individuals with a defined exposure to Andes Virus (ANDV) who are confined or quarantined. Subjects can be included in one of the three tiers and are all followed from one tier to the other and/or to end of quarantine: (a) Tier 1 (Exposure/Enrolment): from X0/E0 to P0 (first RT-qPCR positive); (b) Tier 2 (Pre-symptomatic infection): from P0 to S0 (first symptom onset); (c) Tier 3 (Symptomatic disease): from S0 to clinical outcome (clinical resolution or death). Epidemiological information from their exposure (X0) is also collected. The overarching goal is to delineate the natural history and the virologic and immunologic mechanisms and consequences of infection with sampling intensity matched to biological inflection points, i.e., higher frequency around P0 and symptom onset (S0) and lower intensity elsewhere. Clinical care is not directed by the protocol. All medical decisions remain under treating clinicians. This protocol remains observational and purposely low-intensity because it does not direct clinical care, and uses a trigger-based, phase-adaptive tier structure (X0/E0, P0, S0) that limits biospecimen collection to fixed, low-frequency schedules (generally 1-2 collection days/week with step-down to 1 day/week in weeks 5-6 post-trigger) while daily follow-up is restricted to non-invasive clinical monitoring. Participation in the NAVIS protocol does not restrict or prevent enrollment in other Hantavirus-related emergency responses or interventional clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No age restriction.
- •Persons diagnosed with or exposed to Andes Virus (ANDV). Exposure must comply with the national definition of ANDV exposure in each country, or satisfy at least one of the following criteria:
- •Direct physical exposure to a person with ANDV infection
- •Environmental and proximity exposure to a person with ANDV infection, i.e.:
- •Prolonged presence in an enclosed or poorly ventilated shared airspace. Note: Prolonged exposure is defined as cumulative exposure of 15 minutes or more within a 24-hour period in a confined space, or shared occupancy of an enclosed environment for more than 2 hours (ECDC).
- •Co-habitation in the same household, room, or cabin (e.g., maritime or shared residential settings).
- •Documented proximity during long-haul travel exceeding 4 hours. Note: Proximity is defined as sitting in an adjacent seat, defined as the same row or within two rows in front or behind. Long haul travel includes flight, bus, car or train. See Box 2 for justification of the 4 hour time threshold.
- •Occupational or caregiving exposure
- •Provision of direct healthcare or personal care to a person with ANDV infection without the consistent use of recommended Personal Protective Equipment (PPE).
- •Direct handling of potentially contaminated fomites, such as soiled linens, clothing, or bedding used by a confirmed case.
- •Direct handling of laboratory samples form a confirmed case with noncompliance with standard biosafety protocols.
- •Ability to comply with confinement sampling and follow up procedures.
- •Informed consent by participant, parent/legal guardian, or surrogate where allowed and applicable; assent or consent for children aged <18 years or <16 years as per local regulations.
排除标准
- •1. Current imprisonment (quarantine does not count).
结局指标
主要结局
Time to first virologic detection (X0/E0→P0)
时间窗: 6 weeks
Time from enrolment (X0/E0) to first detectable ANDV RNA (P0)
Blood viral kinetics (trajectory endpoints)
时间窗: 6 weeks
Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance.
Post-symptom RT-qPCR persistence
时间窗: 6 weeks
Duration of RT-qPCR positivity after symptom resolution (where measured)
Serologic conversion timing
时间窗: 6 weeks
Time to IgM positivity, time to IgG positivity
次要结局
- Humoral immune kinetics(6 weeks)
- Longitudinal immune marker trajectories(6 weeks)
- Symptom onset and symptom duration(6 weeks)
- Clinical severity and healthcare utilisation outcomes(6 weeks)
- Standardised in-hospital severity metrics (if hospitalised; clinical data only)(6 weeks)
- Host genetic correlates of infection and disease outcomes(6 weeks)