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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019980
Receipt No. R000023070
Scientific Title Effects of insecticide impregnated ceiling nets on malaria transmission among children in western Kenya: a cluster randomized controlled field trial
Date of disclosure of the study information 2015/12/25
Last modified on 2019/06/25

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Basic information
Public title Effects of insecticide impregnated ceiling nets on malaria transmission among children in western Kenya: a cluster randomized controlled field trial
Acronym Effects of ceiling nets on malaria transmission
Scientific Title Effects of insecticide impregnated ceiling nets on malaria transmission among children in western Kenya: a cluster randomized controlled field trial
Scientific Title:Acronym Effects of ceiling nets on malaria transmission
Region
Africa

Condition
Condition Malaria
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal whether insecticide impregnated ceiling nets reduce malaria vectors and risk of Plasmodium falciparum infection among children
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes PCR based Plasmodium falciparum infection 6, 12, and 18 months after net installation.
amount of hemoglobin 6, 12, and 18 months after net installation.
number of malaria vectors6 months after net installation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Long lasting insecticide impregnated bed nets (LLINs) are distributed to all houses in the study area. The study area was divided to eight areas, and then 4 intervention areas are randomly selected. Immediately after a baseline survey, ceiling nets and are installed in all houses within the intervention areas.
Interventions/Control_2 Only LLINs are distributed to all houses within the control areas.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
7 months-old <
Age-upper limit
131 months-old >=
Gender Male and Female
Key inclusion criteria All children between 7 and 131 months old in the study area. Then, 170 children are randomly selected from each cluster.
Key exclusion criteria Exclude children without consents from their caretakers
Exclude children who do not appear a the testing centers for malaria test
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Noboru
Middle name
Last name Minakawa
Organization Nagasaki University
Division name Institute of Tropical Medicine
Zip code 852-8523
Address 1-12-4 Sakamoto, Nagasaki
TEL 095-819-7810
Email minakawa@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Noboru
Middle name
Last name Minakawa
Organization Nagasaki University
Division name Institute of Tropical Medicine
Zip code 852-8523
Address 1-12-4 Sakamoto, Nagasaki
TEL 095-819-7810
Homepage URL
Email minakawa@nagasaki-u.ac.jp

Sponsor
Institute Institute of Tropical Medicine, Nagasaki University
Institute
Department

Funding Source
Organization Sumitomo Chemical Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Institue of Tropical Medicine, Nagasaki University
Name of secondary funder(s) Institue of Tropical Medicine, Nagasaki University

IRB Contact (For public release)
Organization Nagasaki University Institute of Tropical Medicine
Address 1-12-4 Sakamoto Nagasaki
Tel 095-819-7803
Email soum_nekken@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 SSC No. 2131
Org. issuing International ID_1 Kenya Medical Research Institute
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2019 Year 03 Month 30 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 29 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023070

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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