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

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ClinicalTrials.gov Identifier: NCT01080989
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Flavivirus Infection Alphavirus Infections Malaria Parasitic Disease Leptospirosis Hypertension Metabolic Syndromes Other: diagnosis, treatment and education

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1477 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Sero-prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands
Study Start Date : March 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011


Arms and Interventions

Arm Intervention/treatment
health screening and clinical diagnosis and treatment for p
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.
Other: diagnosis, treatment and education

Drug:

anti-intestinal parasitic drugs:

  1. mebendazole 500mg one dose (For Hook worm infections, Ascariasis, Trichuriasis)
  2. albendazole(400 mg bid * 7days) or Ivermectin(200 mcg/kg/day * 2 days) (For Strongyloidiasis).

Behavior:

  1. 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.
  2. Assist the trained local health personals to educate the patients and the community from the design of teaching materials and the contents.


Outcome Measures

Primary Outcome Measures :
  1. health screening for the community [ Time Frame: one per year ]
    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 :
  1. Patients of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial,and Leptospiral infections. [ Time Frame: one per year ]
    1. 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.
    2. Evaluate the incidence of above diseases after interventions(treatment, management and education capacity buildings).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

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): NCT01080989


Locations
Taiwan
Kaoshing Medical University Chung-Ho Memorial Hospital
Kaoshiung, Taiwan
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Study Chair: Sheng-Hsiung Sheu, Dr Kaohsiung Medical University Chung-Ho Memorial Hospital
More Information

Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01080989     History of Changes
Other Study ID Numbers: KMUH-IRB-980096
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: April 2011

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
solomon islands
malaria
flavivirus
alphavirus
parasite
leptospirosis

Additional relevant MeSH terms:
Leptospirosis
Weil Disease
Syndrome
Infection
Communicable Diseases
Malaria
Metabolic Syndrome X
Parasitic Diseases
Flavivirus Infections
Alphavirus Infections
Disease
Pathologic Processes
Protozoan Infections
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Flaviviridae Infections
RNA Virus Infections
Virus Diseases
Togaviridae Infections