search
Back to results

The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands

Primary Purpose

Flavivirus Infection, Alphavirus Infections, Malaria

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
diagnosis, treatment and education
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Flavivirus Infection focused on measuring solomon islands, malaria, flavivirus, alphavirus, parasite, leptospirosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. For community participants: Health volunteers who are willing to join this study (including the stool and blood testing) after explanation and sign the informed consents.
  2. For hospital cases: The patients ,who were suspicious of malaria, leptospirosis, Alpha-viral(Chikungunya virus, Ross river virus), and flavivirus infections (dengue fever, Japanese encephalitis..ect) by the attending physicians, will be informed about this study by drawing blood samples if they agree to participate.

Exclusion Criteria:

  1. The participants whose stool or blood samples were in-adequate or missing will be excluded from this study.
  2. The participants whose documented personal information is fake or cannot be identifiable will also be excluded from this study.

Sites / Locations

  • Kaoshing Medical University Chung-Ho Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

health screening and clinical diagnosis and treatment for p

Arm Description

The study project can be divided into two parts: (1) health screening for the community and (2) clinical diagnosis and treatment for patients at National Referral Hospital (NRH) in Solomon islands.

Outcomes

Primary Outcome Measures

health screening for the community
Survey the prevalence of intestinal parasitic diseases, flaviviral(Dengue and Japanese encephalitis), Alpha-viral(Chikungunya virus, Ross river virus), leptospiral and malarial infections, and metabolic syndromes(hypertension, diabetes mellitus, hyperlipidemia and gout).

Secondary Outcome Measures

Patients of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial,and Leptospiral infections.
The confirmed malarial cases will be used for pathogen identification and drug resistance analysis. The cases suspicious of Flaviviral (dengue virus, Japanese encephalitis virus), Alpha-viral(Chikungunya virus, Ross river virus), Rickettsial, and Leptospiral infections will be used for the following tests of either one, including ICT (immuno- chromatographic test) rapid test, ELISA, PCR, and the isolation and identification of pathogens. Evaluate the incidence of above diseases after interventions(treatment, management and education capacity buildings).

Full Information

First Posted
August 30, 2009
Last Updated
May 7, 2017
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01080989
Brief Title
The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands
Official Title
The Sero-prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study project can be divided into two parts: (1) health screening for the community and (2) clinical diagnosis and treatment for patients at National Referral Hospital (NRH) in Solomon islands. The health screening includes a questionnaire, stool parasitic screening and blood laboratory tests. A total of 800 subjects will participate in this study. The collected samples are venous blood (20 ml/per subject) and stool in order to conduct the related tests mentioned above. As for the collection of target patients, KMUH will cooperate with NRH to collect two kinds of blood samples: the blood samples of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial, and Leptospiral infections. The expected received cases are 600 each year. The venous blood samples (20 ml/per subject) will be used to conduct related tests mentioned above. At the same time, the subjects will also have to fill out a related questionnaire which includes height, weight, waist line, heath behavior and habit, and past history, etc.
Detailed Description
KMUH plan a series of medical services to Solomon Islands with the expectation that the health and medical standard in Solomon Islands can be improved by medical interaction and the use of high-tech medical instruments. By collecting data from Solomon Islands, KMUH can better understand the health needs, the characteristics of diseases, and the basic health information of Solomon Islanders so that the strategies and the operation goals for further improvement will be more explicit for KMUH's medical teams. The medical service and study project can be divided into two parts: (1) health screening for the community and (2) clinical diagnosis and treatment for patients at NRH. The health screening includes a questionnaire, stool parasitic screening and blood laboratory tests. In the questionnaire, height, weight, waist line, health behavior and habit, and past history are investigated. In the laboratory tests, parasite screening, Malaria rapid check, Flavivirus including dengue virus and Japanese virus, the seroprevalence of Rickettsia, HIV test, Diabetes, gout, cardiovascular risk factors, and fungal infection are included. A total of 800 subjects will participate in this study. The collected samples are venous blood (20ml/per subject) and stool in order to conduct the related tests mentioned above. As for the collection of target patients, KMUH will cooperate with NRH in the Solomon islands to collect two kinds of blood samples: the blood samples of confirmed malarial cases and those of cases suspicious of Flaviviral, Rickettsial,and Leptospiral infections. The expected received cases are 600 each year. The blood samples of confirmed malarial cases will be used for pathogen identification and drug resistance analysis. The blood samples suspicious of Flaviviral(dengue virus, Japanese encephalitis virus), Alpha-viral(Chikungunya virus, Ross river virus), Rickettsial, and Leptospiral infections will be used for the following tests of either one, including ICT (immuno- chromatographic test) rapid test, ELISA, PCR (polymerase chain reaction) and the isolation and identification of pathogens. The venous blood samples (20ml/per subject) will be used to conduct related tests mentioned above. At the same time, the subjects will also have to fill out a related questionnaire which includes height, weight, waist line, heath behavior and habit, and past history, etc. For the confirmed malarial cases, the frequency of blood drawing will start from the diagnosed day, and the 3rd, the 7th , the 14th, the 21st , and the28th days after treatment, with total six times sampling. The blood samples will be used to identify malaria pathogen types and conduct drug resistance analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flavivirus Infection, Alphavirus Infections, Malaria, Parasitic Disease, Leptospirosis, Hypertension, Metabolic Syndromes
Keywords
solomon islands, malaria, flavivirus, alphavirus, parasite, leptospirosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
health screening and clinical diagnosis and treatment for p
Arm Type
Other
Arm Description
The study project can be divided into two parts: (1) health screening for the community and (2) clinical diagnosis and treatment for patients at National Referral Hospital (NRH) in Solomon islands.
Intervention Type
Other
Intervention Name(s)
diagnosis, treatment and education
Intervention Description
Drug: anti-intestinal parasitic drugs: mebendazole 500mg one dose (For Hook worm infections, Ascariasis, Trichuriasis) albendazole(400 mg bid * 7days) or Ivermectin(200 mcg/kg/day * 2 days) (For Strongyloidiasis). Behavior: Education capacity building (for local health personals): promote their ability of diagnosis and education to the community and patients for the associated diseases in this study. Assist the trained local health personals to educate the patients and the community from the design of teaching materials and the contents.
Primary Outcome Measure Information:
Title
health screening for the community
Description
Survey the prevalence of intestinal parasitic diseases, flaviviral(Dengue and Japanese encephalitis), Alpha-viral(Chikungunya virus, Ross river virus), leptospiral and malarial infections, and metabolic syndromes(hypertension, diabetes mellitus, hyperlipidemia and gout).
Time Frame
one per year
Secondary Outcome Measure Information:
Title
Patients of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial,and Leptospiral infections.
Description
The confirmed malarial cases will be used for pathogen identification and drug resistance analysis. The cases suspicious of Flaviviral (dengue virus, Japanese encephalitis virus), Alpha-viral(Chikungunya virus, Ross river virus), Rickettsial, and Leptospiral infections will be used for the following tests of either one, including ICT (immuno- chromatographic test) rapid test, ELISA, PCR, and the isolation and identification of pathogens. Evaluate the incidence of above diseases after interventions(treatment, management and education capacity buildings).
Time Frame
one per year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For community participants: Health volunteers who are willing to join this study (including the stool and blood testing) after explanation and sign the informed consents. For hospital cases: The patients ,who were suspicious of malaria, leptospirosis, Alpha-viral(Chikungunya virus, Ross river virus), and flavivirus infections (dengue fever, Japanese encephalitis..ect) by the attending physicians, will be informed about this study by drawing blood samples if they agree to participate. Exclusion Criteria: The participants whose stool or blood samples were in-adequate or missing will be excluded from this study. The participants whose documented personal information is fake or cannot be identifiable will also be excluded from this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Hsiung Sheu, Dr
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kaoshing Medical University Chung-Ho Memorial Hospital
City
Kaoshiung
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands

We'll reach out to this number within 24 hrs