The efficacy of rupatadine in reducing the incidence of dengue haemorrhagic fever and complications in patients with dengue fever: a randomised, double blind, placebo controlled trial

Phase 2

Recruiting

Conditions: Dengue

Registration Number: SLCTR/2017/024

Lead Sponsor: niversity of Sri Jayewardenapura

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in proportion of individuals who are treated with rupatadine who develop DHF (fluid leakage), as determined by<br><br>1.1. A rise in the haematocrit of >20% from the baseline<br><br>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.<br><br>The day of recovery will be defined when all of the following 3 criteria are fulfilled:<br> • patient afebrile for 24 hours<br> • platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value<br> • return of the haematocrit to the patients baseline ]<br>

Secondary Outcome Measures