UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019980 |
|---|---|
| Receipt number | 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 | 2023/01/20 14:43:18 |
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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
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
minakawa@nagasaki-u.ac.jp
Sponsor or person
Institute
Institute of Tropical Medicine, Nagasaki University
Institute
Department
Personal name
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
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
| 2008 | Year | 02 | Month | 27 | Day |
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
| 2023 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023070
