Flavivirus InfectionNCT01080989
The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands
A study testing diagnosis, treatment and education in people with Flavivirus Infection and Alphavirus Infections, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Flavivirus Infection, Alphavirus Infections, Malaria
- What is being tested?
- diagnosis, treatment and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,477 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sero-prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands
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.
Read the 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.
- Conditions
- Flavivirus Infection, Alphavirus Infections, Malaria, Parasitic Disease, Leptospirosis, Hypertension
- Being tested
- diagnosis, treatment and education
- Keywords
- solomon islands, malaria, flavivirus, alphavirus, parasite, leptospirosis
- Medical subject headings
- Flavivirus Infections, Alphavirus Infections, Malaria, Parasitic Diseases, Leptospirosis, Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis, treatment and educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: diagnosis, treatment and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one per year
Secondary outcomes (1)
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).
Measured: one per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flavivirus InfectionStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,477 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng-Hsiung Sheu, Dr, Study chair, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080989
- Sponsor's protocol ID
- KMUH-IRB-980096
- Status last verified
- Apr 2011
- First submitted
- 30 Aug 2009
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sero-prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands
- ClinicalTrials.gov ID
- NCT01080989
- Acronym / sponsor ID
- KMUH-IRB-980096
- Conditions
- Flavivirus Infection, Alphavirus Infections, Malaria, Parasitic Disease, Leptospirosis, Hypertension
- Keywords
- solomon islands, malaria, flavivirus, alphavirus, parasite, leptospirosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,477 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health screening and clinical diagnosis and treatment for p | Other | Other: diagnosis, treatment and educationThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosis, treatment and educationDrug: 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. | Other | health screening and clinical diagnosis and treatment for p |
Primary outcome
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).
1 secondary outcome
Patients of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial,and Leptospiral infections.
Time frame: one per year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Hsiung Sheu, Dr study chair
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnosis, treatment and education in people with Flavivirus Infection and Alphavirus Infections, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health screening for the community (time frame: one per year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.