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Natural History of Andes Virus Infection (NAVIS)

8. Juli 2026 aktualisiert von: Assistance Publique - Hôpitaux de Paris

Longitudinal Observational Study of the Natural History of Andes Virus Infection

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

15

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Frankreich
      • Bordeaux, Frankreich, 75018
        • Hôpital Pellegrin
      • Paris, Frankreich, 75018
        • Hôpital Bichat
      • Paris, Frankreich, 75018
        • La Pitié Salpêtrière

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Consenting persons of any age who have a confirmed exposure to Andes virus and persons with confirmed Andes virus infection who are placed under confinement or quarantine or clinical care for active Andes virus infection. Participation in the NAVIS protocol does not restrict or prevent enrollment in other Hantavirus-related emergency responses or interventional clinical trials.

Beschreibung

Inclusion Criteria:

  1. No age restriction.

  2. 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:

    1. Direct physical exposure to a person with ANDV infection

    2. 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.

    3. 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.
  3. Ability to comply with confinement sampling and follow up procedures.
  4. 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.

Exclusion Criteria:

  • 1. Current imprisonment (quarantine does not count).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to first virologic detection (X0/E0→P0)
Zeitfenster: 6 weeks
Time from enrolment (X0/E0) to first detectable ANDV RNA (P0)
6 weeks
Blood viral kinetics (trajectory endpoints)
Zeitfenster: 6 weeks
Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance.
6 weeks
Post-symptom RT-qPCR persistence
Zeitfenster: 6 weeks
Duration of RT-qPCR positivity after symptom resolution (where measured)
6 weeks
Serologic conversion timing
Zeitfenster: 6 weeks
Time to IgM positivity, time to IgG positivity
6 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Humoral immune kinetics
Zeitfenster: 6 weeks
IgM and IgG titres over time
6 weeks
Longitudinal immune marker trajectories
Zeitfenster: 6 weeks
Longitudinal immune marker trajectories aligned to P0 and S0 (pre-specified panels)
6 weeks
Symptom onset and symptom duration
Zeitfenster: 6 weeks
Symptom onset date (S0), symptom duration
6 weeks
Clinical severity and healthcare utilisation outcomes
Zeitfenster: 6 weeks
Hospitalisation, ICU admission, organ support (as applicable), mortality (as applicable)
6 weeks
Standardised in-hospital severity metrics (if hospitalised; clinical data only)
Zeitfenster: 6 weeks
WHO Ordinal Scale, SOFA score (if clinically available)
6 weeks
Host genetic correlates of infection and disease outcomes
Zeitfenster: 6 weeks
Genetic associations with infection susceptibility (i.e., infected vs. uninfected among exposed participants). disease severity/progression (e.g., severe vs. mild disease outcomes), key clinical events (e.g., hospitalisation, ICU admission, organ support, mortality) and molecular and immune markers (e.g., differences in viral load kinetics or immune response levels)
6 weeks

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Multi-compartment detection and shedding dynamics
Zeitfenster: 6 weeks
Time-to-first-detection in each compartment (blood/buffy coat, plasma if collected, nasopharyngeal swab, saliva, urine, feces) and lead/lag structure relative to P0, compartment-specific kinetic summaries (peak, time-to-peak, growth/decay rates, and AUC) per compartment, compartment-specific time to clearance and discordance patterns (persistence in non-blood compartments after blood clearance, or vice versa).
6 weeks
Trigger-aligned serology endpoints (P0/S0 anchored)
Zeitfenster: 6 weeks
P0→IgM+, P0→IgG+, S0→IgM+, and S0→IgG+ intervals (trigger-aligned seroconversion timing), early titre kinetic features (e.g., early rise patterns) as predictors of downstream clinical outcomes (hypothesis-generating)
6 weeks
Immune "inflection points" and trajectory phenotypes
Zeitfenster: 6 weeks
Earliest detectable immune activation relative to P0 and relative to S0 ("immune inflection point timing"), and peak/resolution kinetics of immune markers, data-driven immune trajectory phenotypes (e.g., clustered longitudinal patterns) and their association with clinical outcomes.
6 weeks
Time-to-event progression endpoints
Zeitfenster: 6 weeks
Time-to-event endpoints such as P0→hospitalisation/ICU and S0→hospitalisation/ICU/organ support/death (as data allow), for early risk modelling and natural history characterization.
6 weeks
Daily monitoring signal summaries
Zeitfenster: 6 weeks
Descriptive trajectories and derived summaries of daily monitoring measures (temperature, SpO₂, blood pressure, diuresis) and their association with subsequent clinical outcomes (hypothesis-generating)
6 weeks
Convalescence and longer-term outcomes
Zeitfenster: 6 months
Convalescence pattern descriptors and longer-term outcomes through Month 6 (and beyond if extended), including persistence or resolution patterns as captured in follow-up
6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Assistance Publique - Hôpitaux de Paris

Mitarbeiter

International Severe Acute Respiratory and Emerging Infection Consortium

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. Mai 2026

Primärer Abschluss (Geschätzt)

1. August 2026

Studienabschluss (Geschätzt)

1. August 2026

Studienanmeldedaten

Zuerst eingereicht

8. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

14. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • APHP260690

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) and the european regulation (GDPR) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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