Anakinra in Dengue With Hyperinflammation ( AnaDen )

Launched by OXFORD UNIVERSITY CLINICAL RESEARCH UNIT, VIETNAM · Nov 3, 2022

Keywords

ClinConnect Summary

This clinical trial, called AnaDen, is studying the use of a medication called anakinra in patients with dengue fever who are experiencing severe inflammation. Dengue is a viral infection that can cause serious health problems, and in some cases, it leads to a dangerous condition known as hyperinflammation. The main goal of the study is to find out if anakinra can help improve the health of patients with moderate to severe dengue and hyperinflammation compared to those who do not receive the medication (placebo). Researchers will also look at how safe anakinra is and how it affects various health markers in these patients.

To participate in this trial, individuals must be at least 12 years old and hospitalized with a diagnosis of dengue and at least one warning sign of severe illness. They should have high ferritin levels (a protein that can indicate inflammation) and be willing to return for follow-up visits after about 30 days and again after three months. However, certain people, such as those who are pregnant, have other serious health issues, or have recently taken specific medications, cannot join the study. Participants can expect to receive close monitoring and care during the trial, helping researchers learn more about how to treat dengue effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients hospitalised with a clinical diagnosis of dengue and at least 1 warning sign(s) (see appendix) or severe dengue to Emergency department/inpatient wards/Intensive Care wards (ICU),
• • Ferritin levels \> 2000ng/mL
• • ≥ 12 years of age
• • Written informed consent or assent to participate in the study
• • Agree to come back for 2 follow up visits around day 30 of illness (maximum 5 weeks) and at 3 months
• Exclusion Criteria:
• • Pregnancy
• • Localizing features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis
• • Patients taking immunosuppressive drugs or other biologics in last 1 month
• • Patients with underlying malignancy or immunosuppression
• • Children \<12 years
• • Have end-stage renal failure (baseline GFR \< 30ml/min)
• • Being treated for TB
• • Taking any drug with significant interaction with anakinra
• • The study physician judges that the patient is unlikely to attend follow up visit at around 3-4 weeks after fever onset - e.g. due to long travelling distance from the clinic