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
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SLCTR Registration Number
SLCTR/2017/024
Date of Registration
The date of last modification
Jul 19, 2019
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 or Health Condition(s) Studied
Dengue
Scientific Acronym
None
Public Acronym
None
Brief title
Rupatadine for treatment of dengue
Universal Trial Number
U1111-1199-5031
Any other number(s) assigned to the trial and issuing authority
37/17 (ERC: Sri Jayewardenepura)
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
Study Phase
Phase 2-3
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
Exclusion criteria
Known allergies to antihistamines
Inability to take the drugs orally
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
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
Homelessness
Known alcohol dependence or drug abuse
Those with other pre-existing medical conditions that in the opinion of the investigators may impact the interpretation of the study.
Primary outcome(s)
|
1.
Reduction in proportion of individuals who are treated with rupatadine who develop DHF (fluid leakage), as determined by |
[ 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: |
Secondary outcome(s)
|
1.
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: 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 ] |
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
Date of first enrollment
2017-09-25
Date of study completion
Recruitment status
Recruiting
Funding source
Centre for Dengue Research, University of Sri Jayewardenapura
Regulatory approvals
Approved
Status
Approved
Date of Approval
2017-06-16
Approval number
37/17
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
