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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019979
Receipt No. R000023069
Scientific Title Effects of insecticide impregnated ceiling nets on malaria transmission among children: a 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: a randomized controlled field trial
Acronym Effects of insecticide impregnated ceiling nets on malaria transmission
Scientific Title Effects of insecticide impregnated ceiling nets on malaria transmission among children: a randomized controlled field trial
Scientific Title:Acronym Effects of insecticide impregnated 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 indoor resting malaria vectors and risk of Plasmodium falciparum infection among children
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes The number of malaria vectors 2 months after net installation.

PCR based Plasmodium falciparum infection 3 months after net installation
Amount of hemoglobin 3 months after net installation
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Houses in a community are randomly divided into two groups. Ceiling nets are installed in houses in the intervention group.
Interventions/Control_2 The other group is assigned as control, and ceiling nets are not installed.
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
180 months-old >=
Gender Male and Female
Key inclusion criteria All children <= 180 months old.
Key exclusion criteria Exclude children live in concrete houses and large houses (house with more than 3 rooms)
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Noboru
Middle name
Last name Minakawa
Organization Nagasaki University
Division name Institue of Tropical Medicine
Zip code 852-8523
Address 1-12-5 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 Institue of Tropical Medicine
Zip code 8628523
Address 1-12-5 Sakamoto, Nagasaki
TEL 095-819-7810
Homepage URL
Email minakawa@nagasaki-u.ac.jp

Sponsor
Institute Medical Office of Health, Siaya Sub-County, Kenya
Institute
Department

Funding Source
Organization Japan Overseas Cooperation Volunteers
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Secondary IDs
Secondary IDs YES
Study ID_1 xxx
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
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 06 Month 30 Day
Date analysis concluded
2016 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=R000023069

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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