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Home » Trials » SLCTR/2014/023

Effect of Rupatadine compared to placebo in the reducing complications of acute dengue infection

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SLCTR Registration Number

SLCTR/2014/023

Date of Registration

02 Oct 2014

The date of last modification

Mar 03, 2019


Application Summary

Scientific Title of Trial

Effect of Rupatadine compared to placebo in the reducing complications of acute dengue infection

Public Title of Trial

Use of Rupatadine in the treatment of acute dengue infection

Disease or Health Condition(s) Studied

Dengue

Scientific Acronym

None

Public Acronym

None

Brief title

Efficacy of Rupantadine in the treatment of acute dengue infection

Universal Trial Number

U1111-1154-3581

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

03/14 (Ethics Review Committee of the Faculty of Medicine, University of Sri Jayawardenepura)


Trial Details

What is the research question being addressed?

What is the effect of two different dosing regimens of rupatadine compared to placebo on fluid leakage and other complications in acute dengue infection?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Single blinded

Control

Placebo

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 2

Intervention(s) planned

Consenting participants meeting the inclusion exclusion criteria will be randomized into 3 arms.

Participants in arm A will receive one 10mg tablet of rupatadine, plus three placebo tablets once daily until discharge for a maximum of 5 days.

Participants in arm B will receive 40 mg of rupatadine (four 10mg tablets) once daily until discharge for a maximum of 5 days.

Participants in arm C will receive four placebo tablets once daily until discharge for a maximum of 5 days.

All patients will be treated according to the current Dengue guidelines published by the Ministry of Health, Sri Lanka.

The placebo will be identical in appearance to the interventional product and manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka.

Inclusion criteria

  1. Confirmed dengue infection (positive dengue NS1 antigen detection test or presence of dengue specific antibodies)
  2. Informed written consent
  3. Age: between 18-60 years
  4. Duration of illness: less than 5 days
  5. No evidence of vascular leak.

Exclusion criteria

  1. Pregnancy
  2. Known allergies to antihistamines
  3. Individuals who are homeless
  4. Dependency on alcohol or abuse drugs
  5. Hepatic impairment defined as: no previously known liver disease, prolonged prothromin time of 4-6 seconds or more, INR of >1.5
  6. Renal impairment defined as: hypertension and diabetes, GFR <60 ml/min per 1.73 m2, urinary albumin-to-creatinine ratio >30 mg/g , hereditary kidney disease, recurrent or extensive nephrolithiasis, urinary red cell casts, red blood cell count >20 per high power field, Consistent albuminuria

Primary outcome(s)

1.

  1. Proportion of individuals who are treated with rupatadine who develop fluid leakage.

  2. Reduction in fluid leakage by 50% or more in those who are treated with rupatadine.

Fluid accumulation will be assessed by a semi quantitative measure, with classification of ascites as minimal, mild, moderate, severe & massive by looking for the presence of fluid in five areas of the abdomen namely RUQ (perihepatic and morrison's pouch), LUQ (perisplenic), right paracolic gutter, left paracolic gutter and pelvis

 [

Clinical assessments will be carried out at least 3 times a day until discharge.

Laboratory assessments will be carried out at least 4 times a day until discharge.

]

Secondary outcome(s)

1.
  1. Liver failure
  2. Shock
  3. Need for colloids
  4. Need for blood transfusion
  5. Duration of illness
  6. Return of haematocrit to baseline
 [

Clinical assessments will be carried out at least 3 times a day until discharge.

Laboratory assessments will be carried out at least 4 times a day until discharge.

]

Target number/sample size

240

Countries of recruitment

Sri Lanka

Anticipated start date

2014-12-09

Anticipated end date

2015-07-15

Date of first enrollment

2015-04-21

Date of study completion

Recruitment status

Recruiting

Funding source

Centre for Dengue Research, University of Sri Jayawardenapura

Regulatory approvals

MTS/CP/P14/CT/04/2014


State of Ethics Review Approval

Status

Approved

Date of Approval

2014-02-20

Approval number

03/14

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 & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Gathsaurie Malavige
Senior Lecturer
Department of Microbiology, Faculty of Medical Sciences, University of Sri Jayawardenapura
94772443193
94772443193
0112802026
gathsaurie.malavige@ndm.ox.ac.uk

Contact Person for Public Queries

Gathsaurie Malavige
Senior Lecturer
Department of Microbiology, Faculty of Medical Sciences, University of Sri Jayawardenapura
94772443193
94772443193
0112802026
gathsaurie.malavige@ndm.ox.ac.uk

Primary study sponsor/organization

Centre for Dengue Research, University of Sri Jayawardenapura

Centre for Dengue Research, Faculty of Medical Sciences, University of Sri Jayawardenapura
0112802830
0112802830

http://www.cdrsrilanka.com/

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

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


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