The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Flavivirus Infection Alphavirus Infections Malaria Parasitic Disease Leptospirosis Hypertension Metabolic Syndromes |
Other: diagnosis, treatment and education |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Sero-prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands |
- health screening for the community [ Time Frame: one per year ] [ Designated as safety issue: Yes ]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).
- Patients of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial,and Leptospiral infections. [ Time Frame: one per year ] [ Designated as safety issue: Yes ]
- 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).
| Estimated Enrollment: | 1400 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
-
Other: diagnosis, treatment and education
- 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).
- 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.
Drug:
anti-intestinal parasitic drugs:
Behavior:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Jih-Jin Tsai, MD | 886-7-3121101 ext 5677 | jijits@cc.kmu.edu.tw |
| Taiwan | |
| Kaoshing Medical University Chung-Ho Memorial Hospital | Recruiting |
| Kaoshiung, Taiwan | |
| Contact: Jih-Jin Tsai, Dr 886-7-3121101 ext 5677 jijits@cc.kmu.edu.tw | |
| Study Chair: | Sheng-Hsiung Sheu, Dr | Kaohsiung Medical University Chung-Ho Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Tsai, Jih-Jin / Dr., Kaohsiung Medical University Chung-Ho Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01080989 History of Changes |
| Other Study ID Numbers: | KMUH-IRB-980096 |
| Study First Received: | August 30, 2009 |
| Last Updated: | September 6, 2010 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
|
solomon islands malaria flavivirus |
alphavirus parasite leptospirosis |
Additional relevant MeSH terms:
|
Parasitic Diseases Communicable Diseases Infection Hypertension Leptospirosis Weil Disease Malaria Flavivirus Infections Alphavirus Infections Metabolic Syndrome X Vascular Diseases Cardiovascular Diseases |
Gram-Negative Bacterial Infections Bacterial Infections Spirochaetales Infections Protozoan Infections Flaviviridae Infections RNA Virus Infections Virus Diseases Togaviridae Infections Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013