This is a non-interventional, prospective study aim to recruit 200 subjects from National University Hospital, Tan Tock Seng Hospital and Ng Teng Feng General Hospital over a period of 2 years to determine whether differential serum A2M, CMA1 and VEGFA concentrations can predict whether a dengue patient will develop severe disease. Serum A2M, CMA1 and VEGFA concentrations will be quantitated using enzyme-linked immunosorbent assays. The objectives of this study as below:
1. Determine the optimum cut-off for the prediction of DHF/DSS (WHO 1997 classification) and Severe Dengue (SD; WHO 2009 classification).
2. Better understand the characteristics (e.g. daily kinetics) of A2M, CMA1 and VEGFA in Dengue and how their serum concentrations are affected by other variables e.g. patient age and gender, day of sample collection, primary/secondary infection (based on patient memory and/or Standard Diagnostics SD BIOLINE Dengue Duo) and virus serotype.
3. Perform a cost-effectiveness analysis for the adoption of such a Dengue prognostic technology in hospital.
Eligible participants will be aged 21 and above with a laboratory confirmed dengue patients (either positive PCR or positive NS1), and meet all inclusion/exclusion criteria. Each participant will be given an information sheet and informed consent obtained from him/her. Blood will be drawn for PCR Dengue serotyping and measurements of serum concentrations of A2M, CMA1 and VEGFA via quantitative enzyme-linked immunosorbent assays (ELISA). Blood collection will be performed on the day of recruitment.
Participants may be managed as inpatients or outpatients as decided by their treating physician. For participants who are managed as Dengue outpatients, they will be asked to return to the outpatient clinic every day. For both Dengue inpatient and outpatient participants, blood will be drawn every day until they are discharged from care or Day 7 of the study, whichever earlier. If the participants are discharged from care (discharge from hospital or dengue clinic) on the day of recruitment, they will be asked to come back for study visit on Day 2. And 2 ml of blood will be collected for research purpose on Day 2. On the day of discharge, for both Dengue inpatients and outpatients, participants will each be given a questionnaire to complete. A separate questionnaire will also be filled up by the study team for the discharge of each Dengue inpatient participant. Should the participant be discharged prior to Day 7 of the study, a telephone call will be made to the discharged participant on Day 7 of the study to establish his/her health status. Upon completion of the study, each participant will be reimbursed a lump sum of $50.
Data collected will be entered into a paper case report forms and will be transcribed onto eCRF. All participants identifiers will not be collected. The system will allow for audit tracking. During the course of the study, auditors from relevant authorities may visit the study site to review protocol compliance, check electronic case report form (eCRFs) and ensure that the study is being conducted according to Good Clinical Practice (GCP).
