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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019971
Receipt No. R000023020
Scientific Title Effects of long lasting insecticidal nets incorporating piperonyl butoxidae on malaria transmission among children: 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 long lasting insecticidal nets incorporating piperonyl butoxidae on malaria transmission among children: a cluster randomized controlled field trial
Acronym Effects of bed nets incorporating piperonyl butoxidae
Scientific Title Effects of long lasting insecticidal nets incorporating piperonyl butoxidae on malaria transmission among children: a cluster randomized controlled field trial
Scientific Title:Acronym Effects of bed nets incorporating piperonyl butoxidae
Region
Africa

Condition
Condition malaria
Classification by specialty
Infectious disease Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether long lasting insecticidal nets with PBO outperforms LLINs without PBO in reducing risk of Plasmodium falciparum parasite infection in children
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Plasmodium falciparum parasite infection after distribution of the bed nets with PBO
Key secondary outcomes PCR based infection
Slide based infection
Hemoglobin amount

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Immediately after a baseline survey, long lasting insecticide nets (LLINs) are distributed to all houses. Eight clusters are divided to randomly selected 4 intervention clusters and 4 control clusters. LLINs with piperonyl butoxidae (PBO) are distributed to all houses within the intervention clusters (1 LLIN per 2 persons).
Interventions/Control_2 LLINs without PBO are distributed to all houses within the control clusters.
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 Children targeted for malaria transmission survey are aged between 7 to 131 months.
Children between 60 to 131 months old are school children. 170 children are randomly selected from each cluster for survey.
Key exclusion criteria The survey exclude children between 60 to 131 months old who do not attend school.
Target sample size 1360

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, 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, 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 Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kenya Medical Research Institute
Name of secondary funder(s) Nagasaki University

IRB Contact (For public release)
Organization Nagasaki University Institute of Tropical Medicine
Address 1-12-4 Sakamoto Nagasaki Japan
Tel 0958197803
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 05 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 10 Day
Last follow-up date
2014 Year 01 Month 10 Day
Date of closure to data entry
2014 Year 01 Month 10 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 28 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=R000023020

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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