Adaptive Dengue Antiviral Platform Trial

Launched by OXFORD UNIVERSITY CLINICAL RESEARCH UNIT, VIETNAM · Aug 11, 2024

Keywords

ClinConnect Summary

The Adaptive Dengue Antiviral Platform Trial is a research study that aims to test how well new antiviral drugs work for people who are in the early stages of dengue infection. Dengue is a viral illness that can cause high fever and other serious symptoms. The trial will also look at how safe these new drugs are for patients. To be eligible for this study, participants need to be at least 10 years old and have a confirmed diagnosis of dengue with fever lasting less than 48 hours. They must also agree to stay in the hospital for about five days and attend follow-up visits at 30 and 60 days after joining the study.

This trial is not yet recruiting participants, and it is open to both males and females. It's important to note that certain individuals, such as those with severe dengue symptoms, pregnant or breastfeeding women, and people with specific health conditions, cannot participate. Those who do take part will receive close medical care and monitoring during the study to ensure their safety and well-being. This trial represents an important step toward finding effective treatments for dengue, which can help improve patient outcomes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Female or male patients with a clinical diagnosis of dengue virus infection and less than 48 hours of fever
• • Positive NS1 rapid diagnostic test
• • \>= 10 years or ≥ 18 years of age (depending on license of therapeutic being evaluated)
• • Patient is able to give written informed consent or assent for full participation in the study.
• • Agreement to stay in hospital for duration of the intervention (most will be 5 days) and follow-up visits at day 30 and 60 post enrolment.
• Exclusion Criteria:
• • Meets criteria for severe dengue at baseline (severe plasma leakage leading to dengue shock syndrome, fluid accumulation with respiratory distress, severe bleeding, severe organ involvement - AST/ALT\>1000 U/L, impaired consciousness, multiple organ dysfunction)
• • Pregnancy (either clinically confirmed or by urine dipstick for human chorionic gonadotrophin hormone)
• • Breastfeeding women
• • Localising features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis
• • Renal failure (baseline eGFR \< 30ml/min)
• • History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders
• • History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed)
• • Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant
• • Participation or planned participation in a study involving the administration of an investigational compound within the past one month.