The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia
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ClinicalTrials.gov Identifier: NCT02510638
Recruitment Status :
First Posted : July 29, 2015
Last Update Posted : February 1, 2016
Clinical Research Centre, Malaysia
Information provided by (Responsible Party):
Dr. Woon Yuan Liang, Clinical Research Centre, Malaysia
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.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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)