UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019971 |
|---|---|
| Receipt number | 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 | 2023/01/20 14:39:10 |
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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
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
minakawa@nagasaki-u.ac.jp
Sponsor or person
Institute
Institute of Tropical Medicine, Nagasaki University
Institute
Department
Personal name
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
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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7720478/pdf/41182_2020_Article_276.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ajtmh.org/view/journals/tpmd/105/2/article-p461.xml
Number of participants that the trial has enrolled
8620
Results
The differences in anopheline density were -2.5 (95% CI: -6.4 to -0.6) and -1.3 (95% CI: -2.0 to -0.7), respectively. The median PCRpfPRs were 25% (IQR: 11%) in the intervention arm and 52% (IQR: 11%) in the control arm after 5 months and 33% (IQR: 11%) and 45% (IQR: 5%) after 12 months. The PCRpfPR ratios were 0.67 (95% CI: 0.38, 0.91) and 0.74 (95% CI: 0.53, 0.90), respectively.
Results date posted
| 2022 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 22 | Day |
Baseline Characteristics
Children aged 7 months to 10 years
Participant flow
We randomly selected 150 children for each cluster. Then we obtained infromed written consent from their caretakers. We tested children appeared at testing centers.
Adverse events
Not available
Outcome measures
Anopheline density and Plasmodium falciparum polymerase chain reaction (PCR)-positive prevalence (PCRpfPR)
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
| 2008 | Year | 02 | Month | 27 | Day |
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
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 28 | 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=R000023020
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