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The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia

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ClinicalTrials.gov Identifier: NCT02510638
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Woon Yuan Liang, Clinical Research Centre, 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.

Condition or disease
Dengue Fever

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 322 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Nil

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510638


Locations
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Malaysia
Clinical Research Centre, Hospital Kuala Lumpur
KualaLumpur, Malaysia, 59000
Sponsors and Collaborators
Clinical Research Centre, Malaysia

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Responsible Party: Dr. Woon Yuan Liang, Doctor, Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT02510638     History of Changes
Other Study ID Numbers: NMRR-15-452-25624
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral