Clinical Trial: The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia
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.
Detailed Summary:
Dengue infection have resurged and disseminated globally since late 1970s after successful eradication programs of the dengue vector Aedes mosquitoes in Latin America in the 1940s. It 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. Approximately 75% of the current global dengue disease burden comes from the population residing at Southeast Asia and Western Pacific regions, which subsequently lead to the formation of the Asia Pacific Dengue Strategic Plan (2008-2015) and the recent Global Strategy for Prevention and Control (2012-2020) to reduce the dengue burden.
Malaysia is hyper-endemic with all four dengue virus serotypes circulating and responsible for the escalating number of cases over the years. The number of reported dengue cases in Malaysia has increased fourfold from 44.3 per 100,000 population in 1999 to 181 per 100,000 in 2007; with increased in dengue deaths in the adult populations since 2002. Worst still, 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.
The WHO has revised the dengue classification in 2009, which were shown to be more sensitive than the WHO 1997 classification system in predicting severity of dengue. According to this WHO 2009 classification, dengue infection is now categorized into dengue, dengue with warning signs, and severe dengue. The proposed warning signs include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleed, lethargy or restlessness, liver enlargement > 2cm, increase in hematocrit concurrent with r
Sponsor: Clinical Research Centre, Malaysia
Current Primary Outcome: Number of participants with severity of disease [ Time Frame: Participants will be observed for the period of hospital stay, for an average of 1 week duration ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Clinical Research Centre, Malaysia
Dates:
Date Received: July 26, 2015
Date Started: September 2015
Date Completion:
Last Updated: January 28, 2016
Last Verified: January 2016
