Epidemiology of Malaria in Ubon Ratchathani, Thailand
Epidemiology of Malaria in Ubon Ratchathani, Thailand: a Case-control Study
This is an observational study (case-control study) aiming to identify risk factors for malaria infection in health centers or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand.
This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases) subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will be done at each study site.
CASE (Malaria positive) subject will go through the following;
Enrollment visit (Day 0)
1.1 Blood collection of three dried blood spots, and malaria slide. In district hospitals in individuals >14 kg: additional 10ml venous blood will be collected.
1.2 A survey questionnaire which includes patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered.
- Follow up visits (if fever plus Day 42 (+/-3))
2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals: additional 0.5ml venous blood will be collected.
2.2 Short survey questionnaire including questions on symptoms, travel and possible risk behaviors since enrollment will be administered.
CONTROL (Malaria negative) subject will go through the following;
Enrollment visit (Day 0)
1.1 Blood collection to confirm negative malaria slide. In district hospitals: additional 0.5ml venous blood will be collected.
1.2 A survey questionnaire including patient demographics, information on any recent malaria treatment they may have taken, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered.
- Follow up visit: No follow up visit
調査の概要
状態
条件
詳細な説明
Study sites and enrollment:
Patients self-presenting to (1) health centres or(2) malaria posts or (3) district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring a diagnostic test for malaria as determined by the treating clinician will be recruited. Those who are malaria positive will be candidate cases and those who are malaria negative will be candidate controls.
One-to-one matching of cases and controls will be done at each study site. One control will be matched to each case. The matching criteria will be the next malaria negative patient to attend the study site of the same gender and age+/-5 years as an enrolled malaria positive case.
Study procedure:
CASE (Malaria patient defined by positive RDT or blood smear)
Upon enrollment, the below study procedures will be followed;
Blood samples consisting of:
- Three dried blood spots
- A microscopy slide
- In the district hospitals only, 10 ml of venous blood will be taken from the positive for malaria patient.
- A survey include patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phone will be administered to each patient.
CONTROL (Non-malaria patient defined by negative RDT or blood smear)
Upon enrollment, for those negative for malaria, the below study procedures will be follows;
Blood samples consisting of:
- Blood smear
- In the district hospitals only, 0.5 ml of venous blood will also be collected.
- A survey include patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phone swill be administered to each patient.
CASE: Follow-up
- If patients develop a fever after the end of antimalarial treatment and within 42 days after enrollment, they will be asked to return for follow-up as soon as possible on one occasion and then again at 42 (+/-3) days.
- If they do not develop fever within 42 days after enrollment, they will be asked to return for follow up at 42 (+/-3) days.
At the follow-up visit, blood will be taken to test for malaria by microscopy, three dried blood spots will be taken and a short survey administered including questions on symptoms, travel and possible risk behaviors since enrollment.
*In the district hospitals only, 1.5ml of venous blood will be taken
CONTROL: No follow up
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Ubon Rachatani
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Ubon Ratchathani、Ubon Rachatani、タイ、34230
- 募集
- Buntharik Hospital
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コンタクト:
- Tanong Kamsri, Doctor
- メール:drtanong@yahoo.com
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コンタクト:
- Vilasinee Yuwaree
- 電話番号:+66817017165
- メール:vilasinee@tropmedres.ac
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主任研究者:
- Tanong Kamsri, doctor
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Case (Malaria patient defined by positive RDT or blood smear):
Patients of ≥ 6 months of age testing positive for malaria of any species as determined by a positive rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood including individuals with more than one species of Plasmodium.
- Control (Non-malaria patient defined by negative RDT or blood smear):
- Patients > 6 months of age requiring a diagnostic test for malaria but testing negative for malaria by rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood. Controls will be age and gender matched to individual cases at each study site (details below).
Exclusion Criteria:
Not willing to provide written informed consent.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:ケースコントロール
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Case
Malaria patient defined by positive RDT or blood smear
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A survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones
Dried Blood Spot
Venous Blood collection
Slide blood smear
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Control
Non-malaria patient defined by negative RDT or blood smear
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A survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones
Venous Blood collection
Slide blood smear
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Risk factors for Malaria infection
時間枠:2 years
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Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
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2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of malaria infections in Ubon Ratchathani Province
時間枠:2 years
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Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
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2 years
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Prevalence of clinical antimalarial drug resistance
時間枠:2 years
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Prevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand
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2 years
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Human movement leading to spread of malaria and antimalarial drug resistance
時間枠:2 years
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4. Estimates of the potential for spread of malaria and antimalarial drug resistance from Ubon Ratchathani Province, Thailand through human movement to other locations.
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2 years
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Measure antimalarial drug in blood prior to participate in the study
時間枠:2 years
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List of antimalarials which patients have recently taken, if any, prior to presentation in order to estimate drug pressure on the parasite population.
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2 years
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Interviewの臨床試験
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Norwegian Institute of Public HealthStatistics Norway; Society of Interventional Oncology完了