Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product

NCT02288637 | Completed DMC

• 1 other identifier: ITDCZC58
• Study Type: interventional
• Target: 3,840
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria; Anaemia

Outcome Measures

Primary Outcomes (2)

• Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms

  Malaria infection tested using Pf/Pan specific Malaria Rapid Diagnostic Test

  up to 36 months

• Difference in Entomological Inoculation Rate

  Malaria transmission measured by the Entomological Inoculation Rate (EIR) for each mosquito vector species.

  up to 36 months

Secondary Outcomes (5)

• Difference in Anaemia in children

  up to 36 months

• Difference in Mosquito density for each vector species

  Up to 36 months

• Difference in Sporozoite rate for each mosquito vector species

  up to 36 months

• Prevalence of serological antibodies to malaria antigens

  at baseline

• Change in prevalence of insecticide resistance markers including kdr and metabolic mechanisms

  at baseline and up to 36 months

Other Outcomes (5)

• Number of resident owning and using a Long Lasting Insecticidal Net

  at 3, 9, 15, 21, 28, 33 months post intervention

• Number of houses and rooms sprayed

  at time of intervention

• Proportion of household resident reporting being at risk for malaria

  up to 36 months

Study Arms (4)

Conventional Olyset LLIN

EXPERIMENTAL

High coverage (\>80% access) of conventional Olyset LLIN The arm is the standard of care from the National Malaria Control Program

Other: Conventional Olyset LLIN

Olyset Plus LLIN

EXPERIMENTAL

High coverage (\>80% access) of Olyset Plus LLIN

Other: Olyset Plus LLIN

Conventional Olyset LLIN and IRS

EXPERIMENTAL

High coverage (\>80% access) of conventional Olyset LLIN and high coverage IRS (\>80% of the household sprayed) with pirimiphos methyl CS

Other: Conventional Olyset LLIN; Other: IRS

Olyset Plus LLIN and IRS

EXPERIMENTAL

High coverage (\>80% access) of Olyset Plus LLIN and high coverage Indoor Residual Spraying (\>80% of the household sprayed) with pirimiphos methyl CS

Other: Olyset Plus LLIN; Other: Conventional Olyset LLIN

Interventions

Olyset Plus LLIN OTHER

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

Also known as: Long Lasting Insecticidal Net, Olyset® Plus, Sumitomo chemical

Olyset Plus LLIN; Olyset Plus LLIN and IRS

Conventional Olyset LLIN OTHER

Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.

Also known as: Long Lasting Insecticidal Net, Olyset® Net, Sumitomo Chemical

Conventional Olyset LLIN; Conventional Olyset LLIN and IRS; Olyset Plus LLIN and IRS

IRS OTHER

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.

Also known as: Indoor Residual Spraying with Pirimiphos methyl CS, Actellic 300 CS, Syngenta

Conventional Olyset LLIN and IRS

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children severely ill

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

District Muleba

Muleba, Kagera, Tanzania

Location

Related Publications (13)

• West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.

  PMID: 22882836 BACKGROUND

• West PA, Protopopoff N, Rowland M, Cumming E, Rand A, Drakeley C, Wright A, Kivaju Z, Kirby MJ, Mosha FW, Kisinza W, Kleinschmidt I. Malaria risk factors in North West Tanzania: the effect of spraying, nets and wealth. PLoS One. 2013 Jun 7;8(6):e65787. doi: 10.1371/journal.pone.0065787. Print 2013.

  PMID: 23762425 BACKGROUND

• Protopopoff N, Matowo J, Malima R, Kavishe R, Kaaya R, Wright A, West PA, Kleinschmidt I, Kisinza W, Mosha FW, Rowland M. High level of resistance in the mosquito Anopheles gambiae to pyrethroid insecticides and reduced susceptibility to bendiocarb in north-western Tanzania. Malar J. 2013 May 2;12:149. doi: 10.1186/1475-2875-12-149.

  PMID: 23638757 BACKGROUND

• Ngufor C, Tchicaya E, Koudou B, N'Fale S, Dabire R, Johnson P, Ranson H, Rowland M. Combining organophosphate treated wall linings and long-lasting insecticidal nets for improved control of pyrethroid resistant Anopheles gambiae. PLoS One. 2014 Jan 7;9(1):e83897. doi: 10.1371/journal.pone.0083897. eCollection 2014.

  PMID: 24409286 BACKGROUND

• Kilian A, Koenker H, Baba E, Onyefunafoa EO, Selby RA, Lokko K, Lynch M. Universal coverage with insecticide-treated nets - applying the revised indicators for ownership and use to the Nigeria 2010 malaria indicator survey data. Malar J. 2013 Sep 10;12:314. doi: 10.1186/1475-2875-12-314.

  PMID: 24020332 BACKGROUND

• Kabula B, Tungu P, Malima R, Rowland M, Minja J, Wililo R, Ramsan M, McElroy PD, Kafuko J, Kulkarni M, Protopopoff N, Magesa S, Mosha F, Kisinza W. Distribution and spread of pyrethroid and DDT resistance among the Anopheles gambiae complex in Tanzania. Med Vet Entomol. 2014 Sep;28(3):244-52. doi: 10.1111/mve.12036. Epub 2013 Nov 5.

  PMID: 24192019 BACKGROUND

• Pennetier C, Bouraima A, Chandre F, Piameu M, Etang J, Rossignol M, Sidick I, Zogo B, Lacroix MN, Yadav R, Pigeon O, Corbel V. Efficacy of Olyset(R) Plus, a new long-lasting insecticidal net incorporating permethrin and piperonyl-butoxide against multi-resistant malaria vectors [corrected]. PLoS One. 2013 Oct 8;8(10):e75134. doi: 10.1371/journal.pone.0075134. eCollection 2013.

  PMID: 24116029 BACKGROUND

• West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Indoor residual spraying in combination with insecticide-treated nets compared to insecticide-treated nets alone for protection against malaria: a cluster randomised trial in Tanzania. PLoS Med. 2014 Apr 15;11(4):e1001630. doi: 10.1371/journal.pmed.1001630. eCollection 2014 Apr.

  PMID: 24736370 BACKGROUND

• Protopopoff N, Rowland M. Accelerating the evidence for new classes of long-lasting insecticide-treated nets. Lancet. 2018 Jun 16;391(10138):2415-2416. doi: 10.1016/S0140-6736(18)31032-8. No abstract available.

  PMID: 29916383 RESULT

• Protopopoff N, Mosha JF, Lukole E, Charlwood JD, Wright A, Mwalimu CD, Manjurano A, Mosha FW, Kisinza W, Kleinschmidt I, Rowland M. Effectiveness of a long-lasting piperonyl butoxide-treated insecticidal net and indoor residual spray interventions, separately and together, against malaria transmitted by pyrethroid-resistant mosquitoes: a cluster, randomised controlled, two-by-two factorial design trial. Lancet. 2018 Apr 21;391(10130):1577-1588. doi: 10.1016/S0140-6736(18)30427-6. Epub 2018 Apr 11.

  PMID: 29655496 RESULT

• Matowo J, Weetman D, Pignatelli P, Wright A, Charlwood JD, Kaaya R, Shirima B, Moshi O, Lukole E, Mosha J, Manjurano A, Mosha F, Rowland M, Protopopoff N. Expression of pyrethroid metabolizing P450 enzymes characterizes highly resistant Anopheles vector species targeted by successful deployment of PBO-treated bednets in Tanzania. PLoS One. 2022 Jan 24;17(1):e0249440. doi: 10.1371/journal.pone.0249440. eCollection 2022.

  PMID: 35073324 RESULT

• Martin JL, Mosha FW, Lukole E, Rowland M, Todd J, Charlwood JD, Mosha JF, Protopopoff N. Personal protection with PBO-pyrethroid synergist-treated nets after 2 years of household use against pyrethroid-resistant Anopheles in Tanzania. Parasit Vectors. 2021 Mar 10;14(1):150. doi: 10.1186/s13071-021-04641-5.

  PMID: 33691742 RESULT

• Protopopoff N, Mosha JF, Messenger LA, Lukole E, Charlwood JD, Wright A, Kessy E, Manjurano A, Mosha FW, Kleinschmidt I, Rowland M. Effectiveness of piperonyl butoxide and pyrethroid-treated long-lasting insecticidal nets (LLINs) versus pyrethroid-only LLINs with and without indoor residual spray against malaria infection: third year results of a cluster, randomised controlled, two-by-two factorial design trial in Tanzania. Malar J. 2023 Oct 3;22(1):294. doi: 10.1186/s12936-023-04727-8.

  PMID: 37789389 DERIVED

MeSH Terms

Conditions

Malaria; Anemia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: November 11, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

TA (1)