Anakinra in Dengue With Hyperinflammation ( AnaDen ) (NCT05611710) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Anakinra in Dengue With Hyperinflammation ( AnaDen )
Vietnam160 participantsStarted 2023-01-02
Plain-language summary
This study aims to evaluate the effect of anakinra in dengue patients with hyperinflammation as compared to placebo
Primary Objective:
To evaluate the efficacy of Anakinra in moderate-severe dengue patients with hyperinflammation.
Secondary Objectives:
* To assess the safety of anakinra therapy in dengue with hyperinflammation
* To assess the effect of anakinra therapy in patients with dengue on physiological, clinical and virological parameters
* To assess the immunomodulation effects of anakinra in dengue
* Immune cell signatures in dengue with and without anakinra
* To assess difference in gene expression between treatment group compared to non-treatment population
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in modified Sequential Organ Failure Assessment score (mSOFA core, modified for limited resource settings and dengue) within 4 days
Timeframe: baseline, up to day 4
Trial details
NCT IDNCT05611710
SponsorOxford University Clinical Research Unit, Vietnam