Investigation of host and virus factors influencing severity of dengue infections
- Conditions
- Health Condition 1: A90- Dengue fever [classical dengue]Health Condition 2: A91- Dengue hemorrhagic fever
- Registration Number
- CTRI/2022/10/046293
- Lead Sponsor
- Manipal Institute of Virology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients
1. The patients recruited will be between 18 and 60 years old.
2. Patients with fever who are hospitalized and are positive for either DENV IgM, DENV NS1, or both will be recruited for the study.
3. They should not have had a lab-confirmed dengue infection in the past 3 months.
Healthy Controls
1. Healthy controls must be between 18-60 years old
2. Individuals who are not suffering from any disease/ health condition and are not â??sickâ??.
3. They should not have had a lab-confirmed dengue infection in the past 3 months.
Patients
1. Patients unwilling to provide informed consent.
2. Immunocompromised individuals (HIV positive, TB positive, people with cancer/ on chemotherapy, liver cirrhosis, etc) will be excluded from the study.
3. People with mixed infections of malaria, influenza, chikungunya, scrub typhus, leptospirosis, etc will not be included in the study.
4. Women participants who are pregnant at the time of study recruitment will not be included in the study.
Healthy Controls
1. Healthy controls who are found positive for asymptomatic dengue infection with a positive result for anti-Dengue IgM/ NS1 will be excluded from the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Investigation of the serotypes of circulating dengue virus strains as well as differentiating patients based on their primary or secondary infection status <br/ ><br>Correlation of severity with infection status, virus serotype and immune status of the patient <br/ ><br>Exploratory cytokine based proteomic studies to establish the immune signalling molecules undergoing a dysregulation during dengue infection.Timepoint: For statistical appropriation, Omics studies require 24 samples minimum. When this will be achieved, it will be the first study time point. Assuming 50% attrition rate as follow-up loss, 50 participants per group is proposed. <br/ ><br>The time points are <br/ ><br>Day of recruitment in the study, which will usually be the day of hospitalization <br/ ><br>One month after discharge from hospital <br/ ><br>The time point to achieve this will depend on the recruitment of patients with dengue infection which may take 2-3 years. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Correlation studies delineating the molecules that downregulate severity with the patient recovery status in patients under the Dengue without warning signs groups as well as molecules that upregulate disease severity with the recovery status of patients in the dengue with warning signs & severe dengue groups. <br/ ><br> <br/ ><br>Exploring patient & control transcriptomic for comparative studies to establish associations with disease severity, infection status & virus serotype responsible for infection.Timepoint: The timepoint based measurement of the outcomes will depend on the recruitment of dengue patients which may be achieved in 2-3 years considering the sample size