Home » Trials » SLCTR/2017/024


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 -

SLCTR Registration Number

SLCTR/2017/024


Date of Registration

21 Jul 2017

The date of last modification

Jul 21, 2017



Application Summary


Scientific Title of Trial

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


Public Title of Trial

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


Disease of Health Condition(s) Studied

Dengue


Scientific Acronym

None


Public Acronym

None


Brief title

Rupatadine for treatment of dengue


Universal Trail Number

U1111-1199-5031


Any other number(s) assigned to the trial and issuing authority

37/17 (ERC: Sri Jayewardenepura)


Trial Details


What is the research question being addressed?

What is the effectiveness of 40mg of rupatadine when compared to a placebo on reduction of the incidence of dengue haemorrhagic fever and its associated complications in those with dengue viral infections?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

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 tablets of 10mg rupatadine), daily for a duration of 5 days.
Arm B (control arm): 4 tablets of matching placebo, daily for a duration of 5 days

Participants in both arms will be managed according to current national guidelines, Ministry of Health, Sri Lanka.

Participants, health care providers and data collectors will be blinded to the intervention status.


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.



Primary outcome(s)

Reduction in proportion of individuals who are treated with rupatadine who develop DHF (fluid leakage), as determined by
1. A rise in the haematocrit of >20% from the baseline
2. Presence of pleural effusions or ascites by ultra sound scan (for in ward patients)


Primary outcome(s) - Time of assessment(s)

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 outcome

Reduction in complications

  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

  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

  3. Reduction in need of colloids: use of dextran in patients having significant fluid leakage as per National Guidelines

  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

  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

  6. Reduction in sleep disturbances: assessed by an eight point scoring system – the Sleep Condition Indicator (Espie et al., 2014)


Secondary outcome(s) - Time of assessment(s)

Reduction in complications

  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

  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

  3. Reduction in need of colloids: use of dextran in patients having significant fluid leakage as per National Guidelines

  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

  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

  6. Reduction in sleep disturbances: assessed by an eight point scoring system – the Sleep Condition Indicator (Espie et al., 2014)



Target number/sample size

280 (140 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2017-08-15


Anticipated end date

2017-12-31


Recruitment status

Pending


State of ethics review approval

Approved by the Ethical Review Committee of Faculty of Medical Sciences, University of Sri Jayewardenepura on 16th June 2017 (Ref. 37/17)


Funding source

Centre for Dengue Research, University of Sri Jayewardenapura



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. Gathsaurie Neelika Malavige
Director, Centre for Dengue Research
Department of Microbiology, Faculty of Medical Sciences, University of Sri Jayewardenapura, Nugegoda, Sri Lanka
+94772443193
+94772443193

neelika@sjp.ac.lk

Contact Person for Public Queries

Prof. Gathsaurie Neelika Malavige
Director, Centre for Dengue Research
Department of Microbiology, Faculty of Medical Sciences, University of Sri Jayewardenapura, Nugegoda, Sri Lanka
+94772443193
+94772443193

neelika@sjp.ac.lk


Primary study sponsor/organization

University of Sri Jayewardenapura

Centre for Dengue Research, Faculty of Medical Sciences, University of Sri Jayewardenapura, Nugegoda, Sri Lanka
+94772443193

neelika@sjp.ac.lk
www.cdr.sjp.ac.lk

Secondary study sponsor (If any)

None