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Massive dengue drug trial aims to stop deadly progression

NCT ID NCT07543458

Disease control Sponsor: Oxford University Clinical Research Unit, Vietnam Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large study tests several treatments in people hospitalized with moderate or severe dengue. The goal is to find safe, affordable drugs that prevent the disease from getting worse and help patients recover faster. Over 8,800 participants across multiple sites will be enrolled to reduce the burden on hospitals in areas where dengue is common.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 8,800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥5 years * Decision to hospitalise * Clinical diagnosis of dengue * Participants must also have at least one of the following: 1. Severe abdominal pain or tenderness 2. Vomiting more than 3 times in the past 24 hours 3. Pleural effusion or ascites on clinical or radiological examination 4. Absolute haematocrit \>50% 5. 15% increase in haematocrit compared with a baseline sample (defined as the first sample taken during the current illness) 6. Absolute platelet count \<50 × 10⁹/L 7. Absolute platelet count \<100 × 10⁹/L AND a drop \>50 × 10⁹/L in the past 32 hours 8. ALT or AST \>400 IU/L 9. Pulse pressure \<20mmHg or hypotension for age AND at least one of: peripheral capillary refill time \>2 seconds; urine output 0.5ml/kg/hr; cold/clammy peripheries; agitation or altered mental state 10. Bleeding leading to hypotension for age or requiring blood transfusion or medical intervention (e.g. surgery, endoscopy, or vasoactive drugs) 11. Symptomatic bleeding into a critical site (intracranial, intraspinal, intraocular with visual impairment, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome) 12. Requirement for organ support, including vasopressors or inotropes, assisted ventilation, dialysis or haemofiltration, or coma (unresponsive to pain without sedation) or requirement for intravenous antiseizure medications Exclusion Criteria: * Patients on ≥ day 10 of illness or who are clinically improving in the opinion of the managing doctor (the 'recovery phase') will be excluded from recruitment. Other exclusion criteria are specific to individual treatment comparisons, and do not preclude randomisation to other arms of the study. * A participant may not enter a specific treatment comparison if that treatment is considered to be indicated or contraindicated by the responsible clinician.

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Conditions

The condition(s) this trial relates to.

arbovirus infection dengue disease Dengue hemorrhagic fever dengue shock syndrome Flaviviridae infectious disease Flavivirus Infections hemorrhagic fever Mosquito-Borne Diseases RNA Virus Infections vector-borne disease viral hemorrhagic fever viral infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arbovirus infections Dengue Flavivirus infections Hemorrhagic fever Mosquito-borne diseases Rna virus infections Severe dengue Vector-borne diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centro de Atención y Diagnóstico de Enfermedades Infecciosas

    Bucaramanga, Colombia

  • Chittagong Medical College Hospital

    Chittagong, Bangladesh

  • Dhaka Medical College & Hospital

    Dhaka, Bangladesh

  • Dhaka North City Corporation Hospital

    Dhaka, Bangladesh

  • Fundación Valle del Lili

    Cali, Colombia

  • Hospital Queen Elizabeth II, Sabah

    Kota Kinabalu, Malaysia

  • Hospital Regional de Loreto

    Iquitos, Peru

  • Hospital Universitario Erasmo Meoz

    Cúcuta, Colombia

  • Hospital for Tropical Diseases

    Ho Chi Minh City, Vietnam

  • Instituto de Infectologia Emílio Ribas

    São Paulo, Brazil

  • National Academy of Medical Sciences/Bir Hospital

    Kathmandu, Nepal

  • Number 2 Children's Hospital

    Ho Chi Minh City, Vietnam

  • Prince of Songkla University in Southern Thailand

    Songkhla, Thailand

  • San Lazaro Hospital

    Manila, Philippines

  • Siriraj Hospital, Mahidol University

    Bangkok, Thailand

  • Sukraraj Tropical and Infectious Disease Hospital

    Kathmandu, Nepal

  • Universitas Sumatera Utara

    Medan, Indonesia

  • University Malaya Medical Centre

    Kuala Lumpur, Malaysia

More trials for these conditions

Other studies related to the condition(s) this trial covers.