UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019979 |
|---|---|
| Receipt number | 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 | 2023/01/20 14:42:32 |
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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
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
minakawa@nagasaki-u.ac.jp
Sponsor or person
Institute
Medical Office of Health, Siaya Sub-County, Kenya
Institute
Department
Personal name
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
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
https://tropmedhealth.biomedcentral.com/articles/10.1186/s41182-020-00276-x
Publication of results
Unpublished
Result
URL related to results and publications
https://tropmedhealth.biomedcentral.com/articles/10.1186/s41182-020-00276-x
Number of participants that the trial has enrolled
11007
Results
Overall, the cluster level median anopheline densities in the intervention arm and control arm were 0.4 (IQR 0.4) and 2.0 (IQR 1.4), respectively. The adjusted risk ratio was 0.41 (95% CI: 0.29, 0.90; P = 0.029). The median Plasmodium falciparum PCR-positive prevalences were 23% (IQR 8%) in the intervention arm and 42% (IQR 12%) in the control arm. The adjusted risk ratio was 0.53 (95% CI: 0.41, 0.71; P = 0.029).
Results date posted
| 2022 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Children aged 7 months to 10 years
Participant flow
We randomly selected 150 children for each cluster. Then we obtained informed 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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 02 | Month | 27 | Day |
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
| 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=R000023069
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| Registered date | File name |
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