Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT04377451
Eligibility Criteria:
Inclusion Criteria:
* ≥ 10 years to ≤ 30 years of age,
* Clinical diagnosis of dengue (based on WHO 2009 Dengue: Guidelines for Diagnosis, Treatment, Prevention and Control/Vietnam Ministry of Health 2019: Guidelines for Dengue Diagnosis, treatment and prevention)
* Positive NS1 rapid test
* ≤ 3 days (≤ 72 hours) of fever
* BMI \> 25 Kg/m2 (or BMI-for-age \> 1 SD);
* Written informed consent or assent to participate in the study
* Agree to come back for follow up visit around day 21-28 of illness (maximum 1 month)
Exclusion Criteria:
* In all female patients: Pregnancy Localizing features suggesting an alternative diagnosis, e.g. pneumonia, otitis etc.
* History of hypersensitivity to metformin
* Severe infection, including: (1) severe dengue (dengue shock syndrome, severe haemorrhage, severe organ impairment) (2) central nervous system infection, or (3) septicaemia etc…
* Baseline lactate level \> 2.0 mmol/L
* Baseline glucose level \< 3.9 mmol/L OR \< 70 mg/dL
* Already taking metformin or any other regular hypoglycaemic agents, eg. insulin
* Significant diarrhoea and/or vomiting (\> 3 episodes in 24 hours)
* Have acute or chronic renal impairment (baseline GFR \< 30ml/min)
* Liver impairment (baseline AST and ALT \> 250 U/L)
* Being treated for heart failure or have had a recent heart attack (in the last year)
* Taking any drug with significant interaction with metformin
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
30 Years
Study:
NCT04377451
Study Brief:
Protocol Section:
NCT04377451