Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product
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ClinicalTrials.gov Identifier: NCT02288637 |
Recruitment Status :
Completed
First Posted : November 11, 2014
Last Update Posted : April 27, 2018
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The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes region in Tanzania comparing the relative effectiveness of 4 vector control interventions for reducing malaria transmission and controlling vector populations in an area where An gambiae s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal net (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long lasting indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid LLIN or 4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with the LLIN which incorporates a PBO synergist.
The trial will provide epidemiological, entomological, economic and social evidence of impact, as the investigators shall be measuring the reductions in malaria prevalence and malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species ratios and economic cost effectiveness. The proposed trial will demonstrate whether the novel LLIN and long lasting IRS formulation will be more effective for controlling An.gambiae s.s. and reducing malaria prevalence than current practice with the conventional LLIN. There is great interest in conducting this trial. Alternative vector control products are limited and most new insecticides are not suitable for use on LLINs or as IRS.
Condition or disease | Intervention/treatment | Phase |
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Malaria Anaemia | Other: Olyset Plus LLIN Other: Conventional Olyset LLIN Other: IRS | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3840 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product, Separately and Together, Against Malaria Transmitted by Pyrethroid Resistant Mosquitoes. |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | April 2018 |

Arm | Intervention/treatment |
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Experimental: Conventional Olyset LLIN
High coverage (>80% access) of conventional Olyset LLIN The arm is the standard of care from the National Malaria Control Program
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Other: Conventional Olyset LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.
Other Names:
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Experimental: Olyset Plus LLIN
High coverage (>80% access) of Olyset Plus LLIN
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Other: Olyset Plus LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin and the synergist piperonyl butoxide PBO as the active ingredients (AI).The LLIN can withstand repeated washing and retains efficacy over years of use
Other Names:
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Experimental: Conventional Olyset LLIN and IRS
High coverage (>80% access) of conventional Olyset LLIN and high coverage IRS (>80% of the household sprayed) with pirimiphos methyl CS
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Other: Conventional Olyset LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.
Other Names:
Other: IRS Actellic CS (Syngenta), is a microcapsule formulation of the organophosphate insecticide, pirimiphos-methyl. Microencapsulation greatly extends the compound's residual life when applied to interior walls and ceilings. Evaluation by LSHTM in experimental huts in Tanzania showed residual activity of more than a year. Parallel trials in Benin against pyrethroid-resistant mosquitoes killed more than 80% of An. gambiae for up to 10 months.
Other Names:
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Experimental: Olyset Plus LLIN and IRS
High coverage (>80% access) of Olyset Plus LLIN and high coverage Indoor Residual Spraying (>80% of the household sprayed) with pirimiphos methyl CS
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Other: Olyset Plus LLIN
Olyset Plus is a LLIN containing the pyrethroid permethrin and the synergist piperonyl butoxide PBO as the active ingredients (AI).The LLIN can withstand repeated washing and retains efficacy over years of use
Other Names:
Other: Conventional Olyset LLIN Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.
Other Names:
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- Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms [ Time Frame: up to 15 months ]Malaria infection tested using Pf/Pan specific Malaria Rapid Diagnostic Test
- Difference in Entomological Inoculation Rate [ Time Frame: up to 15 months ]Malaria transmission measured by the Entomological Inoculation Rate (EIR) for each mosquito vector species.
- Difference in Anaemia in children [ Time Frame: up to 15 months ]
- Difference in Mosquito density for each vector species [ Time Frame: Up to 15 months ]
- Difference in Sporozoite rate for each mosquito vector species [ Time Frame: up to 15 months ]
- Prevalence of serological antibodies to malaria antigens [ Time Frame: at baseline ]
- Change in prevalence of insecticide resistance markers including kdr and metabolic mechanisms [ Time Frame: at baseline and up to 15 months ]
- Number of resident owning and using a Long Lasting Insecticidal Net [ Time Frame: at 3, 9 and 15 months post intervention ]Self reported ownership and usage using questionnaire confirmed by visual verification. Usage rate (proportion of study population sleeping under an ITN the previous night among those with access and among all population) of the two types of LLIN in the two post intervention years
- Number of houses and rooms sprayed [ Time Frame: at time of intervention ]Self reported praying coverage confirmed by presence of sticker on the door.
- Proportion of household resident reporting being at risk for malaria [ Time Frame: up to 15 months ]Self reported perception
- Change in attitude toward the interventions [ Time Frame: at baseline and up to 15 months ]Self reported attitude
- Cost of the intervention [ Time Frame: up to 3 months ]Based on start up, on-going and capital cost

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Ages Eligible for Study: | 6 Months to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288637
Tanzania | |
District Muleba | |
Muleba, Kagera, Tanzania |
Principal Investigator: | Mark Rowland, Phd | London School of Hygiene and Tropical Medicine | |
Principal Investigator: | Franklin W Mosha, Phd | Kilimanjaro Christian Medical College | |
Principal Investigator: | William Kisinza, Phd | National Institute of Medical Research | |
Principal Investigator: | Immo Kleinshmidt, Phd | London School of Hygiene and Tropical Medicine | |
Principal Investigator: | Natacha Protopopoff, Phd | London School of Hygiene and Tropical Medicine |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT02288637 History of Changes |
Other Study ID Numbers: |
ITDCZC58 |
First Posted: | November 11, 2014 Key Record Dates |
Last Update Posted: | April 27, 2018 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Malaria Protozoan Infections Parasitic Diseases |