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利用者名:
UMIN ID:

試験進捗状況 限定募集中/Enrolling by invitation
UMIN試験ID UMIN000039468
受付番号 R000044823
科学的試験名
一般公開日(本登録希望日) 2020/02/12
最終更新日 2020/08/27

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease
一般向け試験名略称/Acronym
Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease
科学的試験名/Scientific Title
Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease: cluster randomized study
科学的試験名略称/Scientific Title:Acronym
Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease: cluster randomized study
試験実施地域/Region
日本/Japan アフリカ/Africa

対象疾患/Condition
対象疾患名/Condition
Domestic dog bite injury and/or domestic dog mediated human rabies
疾患区分1/Classification by specialty
該当せず/Not applicable
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
Canine rabies is enzootic and, routine control measures, supplies of biologics, relevant recommendations and educational programs are either nonexistent, inoperative or patchy leading to rabies being endemic, wide spread and a neglected disease in Zambia and most other developing countries. There is usually lack of effective educational outreach activities at the community level which has led to gaps in knowledge on best ways to avoid animal bites and administer first aid following animal bites or other forms of exposure. The engagement of community leaders and their communities through the provision of culturally appropriate rabies information, training, and promotion of skill-building activities could improve knowledge of rabies and its prevention. Based on this, an integrated community led-dog management approach will be conducted as a means to increase knowledge and awareness of responsible dog ownership and rabies disease so as to enhance uptake of rabies disease control and prevention activities through dog bite prevention and increased dog vaccination coverage respectively.
目的2/Basic objectives2 安全性/Safety
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Dog vaccination coverage rate
副次アウトカム評価項目/Key secondary outcomes
Knowledge, attitude and practice (KAP) levels of domestic dog-mediated human rabies, its prevention and control.

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 集団/Cluster
ブラインド化/Blinding オープンだが測定者がブラインド化されている/Open -but assessor(s) are blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
行動・習慣/Behavior,custom その他/Other
介入1/Interventions/Control_1
3 days Village based participatory knowledge exchange/discussion and training meetings on dog bites and rabies disease and their prevention. This is for the intervention arm
介入2/Interventions/Control_2
No intervention activities for the control arm
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit

適用なし/Not applicable
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
The study participants target are all permanent residents households heads, adults aged 16 years and above who will agree to join the study.
除外基準/Key exclusion criteria
Household heads and/or representatives who decline to participate in the study and those who may be visitors in the study area/period and are not permanent residents will be excluded.
目標参加者数/Target sample size 360

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Gelly
ミドルネーム Simakechula
Chikuni
所属組織/Organization
Nagasaki University
所属部署/Division name
School of tropical Medicine and Global Health
郵便番号/Zip code 852-8523
住所/Address
1-12-4 Sakamoto, Nagasaki
電話/TEL 080-9801-4159
Email/Email gsimakechula@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Satoshi
ミドルネーム
Kaneko
組織名/Organization
Nagasaki University
部署名/Division name
Institute of Tropical Medicine, Nagasaki University
郵便番号/Zip code 852-8523
住所/Address
1-12-4 Sakamoto, Nagasaki
電話/TEL +81-95-819-7866
試験のホームページURL/Homepage URL http://www.tm.nagasaki-u.ac.jp/nekken/english/research/eco-epidemiology.html
Email/Email skaneko@nagasaki-u.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Nagasaki University, School of Tropical Medicine and Global Health
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Nagasaki University,
School of Tropical Medicine and Global Health
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization その他/Other
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Nagasaki University, School of Tropical Medicine and Global Health Ethical Committee
住所/Address
852-8523, 1-12-4 Sakamoto, Nagasaki, Japan
電話/Tel 095-819-7583
Email/Email tmgh_jimu@ml.nagasaki-u.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 02 12

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
遅れる予定/Delay expected
結果遅延理由/Results Delay Reason
Delayed to start the research due to COVID-19 limitations in travel to the research site and eventual change of research site.
最初の試験結果の出版日/Date of the first journal publication of results
2021 09 30
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 限定募集中/Enrolling by invitation
プロトコル確定日/Date of protocol fixation
2020 04 30
倫理委員会による承認日/Date of IRB
2020 02 28
登録・組入れ開始(予定)日/Anticipated trial start date
2020 08 07
フォロー終了(予定)日/Last follow-up date
2021 03 31
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded
2021 09 30

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2020 02 12
最終更新日/Last modified on
2020 08 27


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044823
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044823

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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