Pilot Survey of Dengue Fever in Solomon Islands

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor:
Collaborators:
Ministry of Foreign Affairs, Republic of China, TAIWAN
Ministry of Health and Medical Services, Solomon Islands
National Referral Hospital,Solomon Islands
Information provided by (Responsible Party):
Wen-Ter Lai (20120080), Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01868399
First received: May 27, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

Since 2009, Kaohsiung Medical University Hospital organized a medical team to provide the medical service for people in Solomon Islands thru Taiwan Health Center at the local. In addition to Malaria and pulmonary tuberculosis, the investigators also found dengue virus, Japanese Encephalitis virus, Chikungunya virus infections and intestinal parasitic infections might be the existing but overlooked and neglected medical issues in Solomon Islands. These infections show similarity in clinical manifestations and usually difficulty in clinical diagnosis, instead these infections rely on the laboratory identification with good laboratory quality and facility.


Condition
Arbovirus Infections

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Pilot Survey of Dengue Fever in Solomon Islands

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • Dengue fever [ Time Frame: at the time of sampling (blood) ] [ Designated as safety issue: Yes ]
    Clinical manifestations, comorbidity and severity


Secondary Outcome Measures:
  • Co-infection and interplay of dengue-like pathogens [ Time Frame: within the first 3 months after blood sampling ] [ Designated as safety issue: No ]
    Identification and Analysis of dengue-like illness and pathogens to investigate the interplay between these coinfections


Biospecimen Retention:   Samples Without DNA

Remaining samples will be provided to the BioBank for the studies of other infectious diseases pathogens.


Estimated Enrollment: 1400
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Suspected dengue fever subjects
No any intervention
Community Healty Residents
No intervention

Detailed Description:

In this study, the investigators plan to investigate the local people, either from the community or the hospitals, to identify the prevalence and incidence of dengue fever, including laboratory identification of related infections for differential diagnosis, including Japanese Encephalitis virus, Chikungunya virus and intestinal parasitic infections. Intestinal parasite survey has been the routine long-term service offered by the Kaohsiung Medical University Hospital in Solomon Islands. At the same time, the subjects enrolled in this study will also be asked the common medical illness in Solomon Islands (i.e. malaria, pulmonary tuberculosis and metabolic syndrome etc.) in order to delineate the association of dengue fever and these acute and chronic illness.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Residents of Solomon Islands
  • people who understand the purpose of the study
  • people who agree to sign the informed consent
Criteria

Inclusion Criteria:

  • healthy volunteer
  • reported dengue virus infection volunteer
  • people who understand the purpose of the study and agree the to sign the informed consent

Exclusion Criteria:

  • people who refuse to join the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868399

Contacts
Contact: Wen-Ter Lai, MD +886-7-3121101 ext 5104
Contact: Jih-Jin Tsai, MD, Ph. D. +886-7-3121101 ext 6358 jijits@cc.kmu.edu.tw

Locations
Taiwan
Tropical Medicine center Recruiting
Kaohsiung city, Taiwan, 807
Principal Investigator: Jih-Jin Tsai, MD. Ph. D.         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Ministry of Foreign Affairs, Republic of China, TAIWAN
Ministry of Health and Medical Services, Solomon Islands
National Referral Hospital,Solomon Islands
Investigators
Study Chair: Wen-Ter Lai, MD Kaohsiung Medical University Chung-Ho Memorial Hospital
Principal Investigator: Jih-Jin Tsai, MD, Ph. D. Kaohsiung Medical University Chung-Ho Memorial Hospital
  More Information

No publications provided

Responsible Party: Wen-Ter Lai (20120080), Superintendent, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01868399     History of Changes
Other Study ID Numbers: KMUH-IRB-20120080
Study First Received: May 27, 2013
Last Updated: January 28, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
dengue virus

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

ClinicalTrials.gov processed this record on July 29, 2014