The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia

NCT02510638 | Completed

• 1 other identifier: NMRR-15-452-25624
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

Dengue infection has been identified as the fastest spreading mosquito-borne viral disease by World Health Organization (WHO), which affects more than 2.5 billion people living in the subtropical and tropical regions. Malaysia is hyper-endemic with all four dengue virus serotypes circulating and responsible for the escalating number of cases over the years. As of 28 February 2015, there are 62 deaths secondary to dengue infection being reported in Malaysia; and the total number of dengue cases reported in the same period was 23,966 which is 46% higher than the same reporting period of 2014. Although dengue virus has been identified for so many years and plenty of research work has been carried out, it was proven that there are still many aspects that we are not too sure about the disease. Therefore, this multi-center, observational cohort study is designed to investigate the clinical course of hospitalized dengue infection in Malaysia. The study population of this study consists of male or female patients with dengue to be randomly sampled from hospitals in Malaysia. This study will be conducted in 2 stages whereby the 1st stage will only focus on the basic social and clinical data to describe the clinical course of dengue as general and the 2nd stage will collect the more detailed clinical and management data to describe the detailed clinical course, management and prognosis of dengue. All hospital participation in this study is voluntary, and approval will be obtained from National Institute of Health (NIH) and Medical Research Ethics Committee (MREC) prior to any recruitment.

Conditions

Dengue Fever

Outcome Measures

Primary Outcomes (1)

• Number of participants with severity of disease

  Participants will be observed for the period of hospital stay, for an average of 1 week duration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of male or female patients with Dengue to be randomly sampled from hospitals in Malaysia. Approximately 384 patients will be enrolled. Sampling Frame: A sample of dengue cases who visited general practitioner or who were hospitalized from year 2009 till 2015 will be sampled using PIK and Health insurance claims database. Sampling: A random sampling will be done to select the samples. In order to do it, each subject in the sampling frame will be given an unique number (e.g.: 001, 002, 003,… etc) according to the sequence of notification date. Then, the subjects will be selected randomly by using randomizer.org software.

You may qualify if:

• Stage 1:
• Discharge diagnosis with International Classification of Disease (ICD) code A90 - A99
• Availability of minimal dataset (name, IC, age, sex, diagnosis, date admit, date discharge, discharge status)
• Stage 2:
• Laboratory confirmed dengue (Non-structural 1 antigen, dengue IgM, high-titre dengue IgG, and dengue polymerase chain reaction (PCR) positive)

You may not qualify if:

• Nil

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead

Study Sites (1)

Clinical Research Centre, Hospital Kuala Lumpur

KualaLumpur, 59000, Malaysia

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 26, 2015
• First Posted: July 29, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

MY (1)