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

NCT01080989 | Completed

• 1 other identifier: KMUH-IRB-980096
• Study Type: interventional
• Target: 1,477
• Locations: 1 country
• Sites: 1

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.

Conditions

Flavivirus Infection; Alphavirus Infections; Malaria; Parasitic Disease; Leptospirosis; Hypertension; Metabolic Syndromes

Keywords

solomon islands; malaria; flavivirus; alphavirus; parasite; leptospirosis

Outcome Measures

Primary Outcomes (1)

• 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).

  one per year

Secondary Outcomes (1)

• Patients of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial,and Leptospiral infections.

  one per year

Study Arms (1)

health screening and clinical diagnosis and treatment for p

OTHER

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

Interventions

diagnosis, treatment and education OTHER

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.

health screening and clinical diagnosis and treatment for p

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaoshing Medical University Chung-Ho Memorial Hospital

Kaoshiung, Taiwan

Location

MeSH Terms

Conditions

Flavivirus Infections; Alphavirus Infections; Malaria; Parasitic Diseases; Leptospirosis; Hypertension; Metabolic Syndrome

Interventions

Therapeutics; Educational Status

Condition Hierarchy (Ancestors)

Flaviviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Togaviridae Infections; Protozoan Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Sheng-Hsiung Sheu, Dr

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2009
• First Posted: March 5, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 9, 2017

Record last verified: 2011-04

Locations

TW (1)