Dengue
Conditions
Interventions
The study will be carried out at the National Infectious Diseases Hospital, Sri Lanka.
Participants will be allocated using simple randomization.
Arm A (intervention arm): 40mg rupatadine (4 tablet
Sponsors
University of Sri Jayewardenapura
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 18-60 years 2. Dengue infection confirmed by a positive dengue NS1 antigen detection test (rapid immununochromatographic assays (rapid strip tests) at the out patient department) 3. Duration of fever: <3 days 4. No evidence of vascular leak.
Exclusion criteria
Exclusion criteria: 1. Known allergies to antihistamines 2. Inability to take the drugs orally 3. Known hepatic impairment defined as follows (all 3 criteria) • History or clinical record of pre-existing liver disease • Prolonged prothromin time of 4-6 seconds or more • INR of >1.5 4. Known renal impairment defined as: • History or clinical record of pre-existing renal disease, predicted GFR <60 ml/min per 1.73 m2, hereditary kidney disease or recurrent or extensive nephrolithiasis 5. Homelessness 6. Known alcohol dependence or drug abuse 7. Those with other pre-existing medical conditions that in the opinion of the investigators may impact the interpretation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in proportion of individuals who are treated with rupatadine who develop DHF (fluid leakage), as determined by 1.1. A rise in the haematocrit of >20% from the baseline 1.2. Presence of pleural effusions or ascites by ultra sound scan (for in ward patients) [Daily in the outpatient setting until recovery or for in-ward patients, daily until discharge from hospital. The day of recovery will be defined when all of the following 3 criteria are fulfilled: • patient afebrile for 24 hours • platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value • return of the haematocrit to the patients baseline ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in complications 1.1. Reduction in liver failure (prolonged prothrombin time of 4-6 seconds or more and INR of >1.5 in the absence of any previously known liver disease 1.2. Reduction in development of shock: Shock will be defined as a pulse pressure of >20 mmHg or a drop in the systolic blood pressure of 30mmHg or more 1.3. Reduction in need of colloids: use of dextran in patients having significant fluid leakage as per National Guidelines 1.4. Reduction in need of blood transfusion/s: as per National Guidelines. Use of even 1 blood transfusion will be considered as the patient having significant fluid leakage 1.5. Reduction in duration of the illness. The first day of the illness will be defined as the day in which the patient developed fever. The day of recovery will be defined when all of the following 3 criteria are fulfilled: • patient afebrile for 24 hours • platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value • return of the haematocrit to the patients baseline 1.6. Reduction in sleep disturbances: assessed by an eight point scoring system – the Sleep Condition Indicator (Espie et al., 2014) [Daily in the outpatient setting until recovery or for in-ward patients, daily until discharge from hospital. Then again at 14 days and 30 days since onset of illness ] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Gathsaurie Neelika Malavige
Director, Centre for Dengue Research
Outcome results
None listed