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Epidemiology of Malaria in Ubon Ratchathani, Thailand

2017年1月19日 更新者:University of Oxford

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;

  1. 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.

  2. 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;

  1. 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.

  2. Follow up visit: No follow up visit

調査の概要

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;

  1. 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.
  2. 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;

  1. Blood samples consisting of:

    • Blood smear
    • In the district hospitals only, 0.5 ml of venous blood will also be collected.
  2. 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

観察的

入学 (予想される)

660

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ubon Rachatani
      • Ubon Ratchathani、Ubon Rachatani、タイ、34230
        • 募集
        • Buntharik Hospital
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Tanong Kamsri, doctor

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6ヶ月歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients self-presenting to health centres or malaria posts or 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.

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
Case
Malaria patient defined by positive RDT or blood smear
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
Control
Non-malaria patient defined by negative RDT or blood smear
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

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
Risk factors for Malaria infection
時間枠:2 years
Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
2 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of malaria infections in Ubon Ratchathani Province
時間枠:2 years
Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
2 years
Prevalence of clinical antimalarial drug resistance
時間枠:2 years
Prevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand
2 years
Human movement leading to spread of malaria and antimalarial drug resistance
時間枠:2 years
4. Estimates of the potential for spread of malaria and antimalarial drug resistance from Ubon Ratchathani Province, Thailand through human movement to other locations.
2 years
Measure antimalarial drug in blood prior to participate in the study
時間枠:2 years
List of antimalarials which patients have recently taken, if any, prior to presentation in order to estimate drug pressure on the parasite population.
2 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年12月1日

一次修了 (予想される)

2018年12月1日

研究の完了 (予想される)

2018年12月1日

試験登録日

最初に提出

2016年12月9日

QC基準を満たした最初の提出物

2016年12月13日

最初の投稿 (見積もり)

2016年12月14日

学習記録の更新

投稿された最後の更新 (見積もり)

2017年1月20日

QC基準を満たした最後の更新が送信されました

2017年1月19日

最終確認日

2017年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • EPI1601

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

According to Mahidol-Oxford Tropical Medicine Research Unit policy

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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