Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Factors Associated With Poor Dengue Outcomes in Malaysia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02510690
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Dr. Goh Pik Pin, Clinical Research Centre, Malaysia

Brief Summary:
This study aims to analyse the results of national data collected by the e-Dengue Information System in order to determine the factors associated with disease outcomes in all patients registered from January 2013 to December 2014.

Condition or disease
Dengue Fever

Detailed Description:

Dengue is the most important arthropod borne viral disease in humans. The World Health Organization has estimated that more than 70% of the global at risk population live in the WHO southeast Asia and Western Pacific region, which account for nearly 75% of global disease burden from dengue. The number of reported cases of dengue in Malaysia has increased fourfold from 44.3 per 100 000 population in 1999 to 181 per 100 000 in 2007. Serologically confirmed cases are approximately half of the number of reported cases. An increase in dengue deaths in the adult populations has been observed since 2002. A study in Vietnam showed that women and children appear to have increased risk of dengue shock syndrome and death. Children aged 6-10 years had highest risk of Dengue Shock Syndrome (DSS). However, mortality was highest in younger children. However, in a study of 560 adult dengue patients in Martinique, Thomas L et al found that severe dengue were mainly in males, elderly, and presented with abdominal pain, cough and diarrhoea. At present, there is no vaccine or cure for dengue. Treatment is mainly supportive and for symptom relief. Various measures have been employed to decrease the incidence of dengue - these have been mainly by public health measures. However, 2014 has seen a dramatic rise in the number of confirmed dengue cases as well as mortality.

This study aims to analyse the results of national data collected by the e-Dengue Information System in order to determine the factors associated with disease outcomes in all patients registered from January 2013 to December 2014.

An epidemiological observational study will be done by utilizing e-dengue data from year 2013 till year 2014. The inclusion criteria is all dengue cases registered in the e-Dengue information system 2013-2014; and there is no exclusion criteria.

The primary outcome measurement is the disease outcome which included recovery, hospitalisation and death.

All data collected will be analyzed by using descriptive analysis, the prevalence/incidence will be estimated; and regression model will be generated.


Layout table for study information
Study Type : Observational
Actual Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Associated With Poor Dengue Outcomes in Malaysia
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue




Primary Outcome Measures :
  1. Mortality rate [ Time Frame: through out the length of hospital stay, an average of 7 days ]
    to determine the mortality rate secondary to dengue

  2. The proportion of dengue patient who recover from dengue and discharged [ Time Frame: through out the length of hospital stay, an average of 7 days ]
  3. Number of participants with Disease severity [ Time Frame: through out the length of hospital stay, an average of 7 days ]
    according to WHO classification



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All dengue cases that registered under e-Dengue Information System 2013-2014
Criteria

Inclusion Criteria:

  • All dengue cases e-Dengue Information System 2013-2014

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): NCT02510690


Locations
Layout table for location information
Malaysia
Clinical Research Centre, Hospital Kuala Lumpur
KualaLumpur, Malaysia, 59000
Sponsors and Collaborators
Clinical Research Centre, Malaysia
University of Malaya

Layout table for additonal information
Responsible Party: Dr. Goh Pik Pin, Doctor, Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT02510690     History of Changes
Other Study ID Numbers: NMRR-14-1275-22205
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral