UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045079 |
|---|---|
| Receipt number | R000051478 |
| Scientific Title | Evaluation of OlysetPlus ceiling net in Lake Victoria basin, Kenya: study protocol for a cluster-randomized trial |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/08/07 12:54:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of OlysetPlus ceiling net in Lake Victoria basin, Kenya
Acronym
OPCeNTILV
Scientific Title
Evaluation of OlysetPlus ceiling net in Lake Victoria basin, Kenya: study protocol for a cluster-randomized trial
Scientific Title:Acronym
OPCeNTILV
Region
| Africa |
Condition
Condition
malaria
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the effect of OlysetPlus ceiling nets on malaria burden on Mfangano Island, Homa Bay County, Kenya
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Prevalence of Plasmodium infections in children three to fifteen years six and twelve months after OlysetPlus ceiling net installation; (2) Incidence of malaria across all ages twelve months after net installation; (3) Density and composition of Anopheles vectors six and twelve months after net installation
Key secondary outcomes
(1) Hemoglobin levels in children three to fifteen years six and twelve months after net installation; (2) Prevalence of antibodies against Anopheles salivary proteins and Plasmodium antigens across all ages twelve months after net installation; (3) Genomic profiles of Plasmodium parasites at six and twelve months after net installation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention: OlysetPlus ceiling nets are installed permanently in houses randomly assigned to the intervention arm.
Interventions/Control_2
Control: No OlysetPlus ceiling nets are installed in houses randomly assigned to the control arm.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Households with at least one permanent resident on Mfangano Island
Key exclusion criteria
(1) Temporary residents; (2) residents living in temporary structures; (3) residents planning to leave or stay outside their permanent home for longer than one month over the study period (12 months)
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kaneko |
Organization
Osaka Metropolitan University
Division name
Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-Ku, Osaka, Japan
TEL
666453761
akirakaneko555@gmail.com
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Kagaya |
Organization
Osaka Metropolitan University
Division name
Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL
666453761
Homepage URL
wataru.kagaya@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan International Cooperation Agency-Science and Technology Research Partnership for Sustainable Development (JICA-SATREPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mount Kenya Unversity
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University
Address
1-4-3 Asahi-machi, Abeno-ku, 545-8585 Osaka, Japan
Tel
666453611
ethics@med.osaka-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | 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
548
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
| 2021 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051478
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
