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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 April 2022
Main ID:  NCT02288637
Date of registration: 06/10/2014
Prospective Registration: No
Primary sponsor: London School of Hygiene and Tropical Medicine
Public title: Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product
Scientific title: Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product, Separately and Together, Against Malaria Transmitted by Pyrethroid Resistant Mosquitoes.
Date of first enrolment: September 2014
Target sample size: 3840
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02288637
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Tanzania
Contacts
Name:     Natacha Protopopoff, Phd
Address: 
Telephone:
Email:
Affiliation:  London School of Hygiene and Tropical Medicine
Name:     William Kisinza, Phd
Address: 
Telephone:
Email:
Affiliation:  National Institute of Medical Research
Name:     Mark Rowland, Phd
Address: 
Telephone:
Email:
Affiliation:  London School of Hygiene and Tropical Medicine
Name:     Immo Kleinshmidt, Phd
Address: 
Telephone:
Email:
Affiliation:  London School of Hygiene and Tropical Medicine
Name:     Franklin W Mosha, Phd
Address: 
Telephone:
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Affiliation:  Kilimanjaro Christian Medical College
Key inclusion & exclusion criteria

Inclusion Criteria:

For the Household

- Having a children from 6 months to 14 years old in the household

- Provide written consent For the children

- Having between 6 months to 14 years

- Permanent residence in a selected household

Exclusion Criteria:

- Children severely ill



Age minimum: 6 Months
Age maximum: 14 Years
Gender: All
Health Condition(s) or Problem(s) studied
Anaemia
Malaria
Intervention(s)
Other: Conventional Olyset LLIN
Other: Olyset Plus LLIN
Other: IRS
Primary Outcome(s)
Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms [Time Frame: up to 36 months]
Difference in Entomological Inoculation Rate [Time Frame: up to 36 months]
Secondary Outcome(s)
Prevalence of serological antibodies to malaria antigens [Time Frame: at baseline]
Difference in Sporozoite rate for each mosquito vector species [Time Frame: up to 36 months]
Difference in Anaemia in children [Time Frame: up to 36 months]
Difference in Mosquito density for each vector species [Time Frame: Up to 36 months]
Change in prevalence of insecticide resistance markers including kdr and metabolic mechanisms [Time Frame: at baseline and up to 36 months]
Secondary ID(s)
ITDCZC58
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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