NCT07799168

Brief Summary

The goal of this observational study is to investigate the natural history of dengue in hospitalised patients in Vietnam, to better understand the disease process, and utilise the data to improve future clinical trials. The main questions it aims to answer are: In participants hospitalised with dengue in Vietnam:

  • Recording of their routine clinical data
  • Regular blood tests
  • Regular ultrasound scans
  • A follow up appointment.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

1.4 years

First QC Date

June 5, 2026

Last Update Submit

August 28, 2026

Conditions

Dengue

Keywords

denguevascular leakmulti-state models

Outcome Measures

Primary Outcomes (1)

  • Degree of vascular leak

    Presence and severity of vascular leak (none, moderate, severe) per Tomashek et al. 2018 consensus definitions - composite of change of haematocrit from baseline, presence of ascites/pleural effusion by point of care ultrasound and presence of respiratory/cardiovascular compromise.

    From enrollment until day 10 of illness, or discharge

Secondary Outcomes (11)

  • Multi-state model evaluation - precision

    Assessed at 3 days and 5 days post admission

  • Multi-state model evaluation: model fit

    From enrollment until day 10 of illness or discharge

  • Viral dynamics

    From enrollment until day 10 of illness, or discharge

  • Degree of thrombocytopenia

    From enrollment until day 10 of illness or discharge

  • Degree of bleeding

    From enrollment until day 10 of illness or discharge

  • +6 more secondary outcomes

Study Arms (3)

Hospitalised Cohort

Patients hospitalised with dengue with warning signs or severe dengue

Diagnostic Control Cohort

Patients with non-dengue febrile illness

Platelet Control Cohort

Healthy Vietnamese volunteers

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to Khánh Hòa Hospital of Tropical Diseases, Nha Trang, Vietnam.

You may qualify if:

  • Meet the 2009 WHO criteria for dengue with warning signs or severe dengue AND
  • Are being admitted as an inpatient AND
  • Have documented standard-of-care laboratory confirmation of dengue (defined as either positive by molecular assay (e.g. reverse transcription polymerase chain reaction) OR positive by antigen testing (non-structural protein-1) OR positive Immunoglobulin M (IgM) combined with clinical diagnosis of dengue by attending physician. AND
  • Were born in Vietnam (only for platelet phenomics substudy)
  • Have a documented fever at assessment AND
  • Have a documented negative standard-of-care dengue test, with no clinical diagnosis of dengue AND
  • Were born in Vietnam (only for platelet phenomics substudy)
  • Vietnamese-born adults ≥16 years of age with no history of febrile illness in the preceding 14 days.

You may not qualify if:

  • Receiving an experimental dengue treatment during their illness.
  • Inability to provide written, informed consent AND no legal guardian able to provide written, informed consent in the event of incapacity.
  • Clinician-determined unsuitability for recruitment.
  • Any non-steroidal anti-inflammatory, antiplatelet or anticoagulant medication received in preceding 7 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagasaki University Vietnam Research Station, Nha Trang

Nha Trang, Vietnam

Location

Related Publications (3)

  • McBride A, Chanh HQ, Trieu HT, Tran HB, Anderson KB, Aogo RA, Avirutnan P, Tran LHB, Chan XH, Chandra R, Chang A, Chia PY, Daniel V, Demidova A, Consuegra Rodriguez MP, Figueiredo-Mello C, Garcia-Gallo E, Garrood W, Tam DTH, Jaenisch T, Kain M, Katzelnick L, Lam PK, Leopold SJ, Lim C, M Siqueira A, Malavige GN, Malik S, Merson L, Meyer-Andrieux I, Moorman N, Neal A, Nguyen NM, Ong HC, Pett S, Rojas-Garrido E, Schilling W, Shahrin L, Sjo P, Syed Omar SF, Teixeira M, Tirupakuzhi Vijayaraghavan BK, Villar L, Vuong NL, Waickman A, Wills B, Kestelyn E, Watson J, Munblit DB, Yacoub S. Dengue therapeutics consortium 2025: a global collaboration in action. BMJ Public Health. 2026 Jan 12;4(1):e004043. doi: 10.1136/bmjph-2025-004043. eCollection 2026.

    PMID: 41561567BACKGROUND

  • Vuong NL, Lam PK, Ming DKY, Duyen HTL, Nguyen NM, Tam DTH, Duong Thi Hue K, Chau NV, Chanpheaktra N, Lum LCS, Pleites E, Simmons CP, Rosenberger KD, Jaenisch T, Bell D, Acestor N, Halleux C, Olliaro PL, Wills BA, Geskus RB, Yacoub S. Combination of inflammatory and vascular markers in the febrile phase of dengue is associated with more severe outcomes. Elife. 2021 Jun 22;10:e67460. doi: 10.7554/eLife.67460.

    PMID: 34154705BACKGROUND

  • Tomashek KM, Wills B, See Lum LC, Thomas L, Durbin A, Leo YS, de Bosch N, Rojas E, Hendrickx K, Erpicum M, Agulto L, Jaenisch T, Tissera H, Suntarattiwong P, Collers BA, Wallace D, Schmidt AC, Precioso A, Narvaez F, Thomas SJ, Edelman R, Siqueira JB, Cassetti MC, Dempsey W, Gubler DJ. Development of standard clinical endpoints for use in dengue interventional trials. PLoS Negl Trop Dis. 2018 Oct 4;12(10):e0006497. doi: 10.1371/journal.pntd.0006497. eCollection 2018 Oct.

    PMID: 30286085BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, PaxGene fibonucleic acid tubes, (ethylenediaminetetraacetic acid) EDTA whole blood for diagnostic purposes.

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Central Study Contacts

Matthew JW Kain

CONTACT

+44 151 705 3100matthew.kain@lstmed.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2026

First Posted

September 2, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Anonymised study results will be made publicly available through scientific publications and, where appropriate, data repositories. Requests from bona fide researchers for access to de-identified participant-level data will be considered on a case-by-case basis, subject to applicable ethical approvals, participant consent, and local and institutional policies.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE

Locations

VN(1)