- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01697852
The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention
Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania
The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS.
Findings from this study are expected to inform decision making so that resource utilization can be optimised.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Kagera
-
Muleba, Kagera, Tanzania
- Rekruttering
- PAMVERC office
-
Kontakt:
- Natacha Protopopoff, PHD
- E-mail: nprotopopoff@gmail.com
-
Ledende efterforsker:
- Natacha Protopopoff, PHD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- resident in selected cluster (village)
Exclusion Criteria:
- Not resident in selected cluster (village)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: LLIN plus IRS
LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide
|
2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart
Andre navne:
Long lasting Insecticide treated mosquito net
Andre navne:
|
|
Aktiv komparator: LLIN only
LLIN by universal coverage campaign
|
Long lasting Insecticide treated mosquito net
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Prevalence of malarial infection in children 6 months to 10 years
Tidsramme: 9 months post randomisation
|
9 months post randomisation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Moderate to severe anaemia in children under 5 years
Tidsramme: 9 months post randomisation
|
9 months post randomisation
|
|
Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years
Tidsramme: 6 months post randomisation
|
6 months post randomisation
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Entomological Innoculation Rate
Tidsramme: Malaria season post randomisation(Average value during 6 months after randomisation)
|
Malaria season post randomisation(Average value during 6 months after randomisation)
|
|
Relative abundance of adult Anopheles mosquitoes by species
Tidsramme: Malaria season post randomisation (Average value during 6 months after randomisation)
|
Malaria season post randomisation (Average value during 6 months after randomisation)
|
|
genotypic markers of insecticide resistance in malaria vector mosquitoes
Tidsramme: Malaria season post randomisation (Average value during 6 months after randomisation)
|
Malaria season post randomisation (Average value during 6 months after randomisation)
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark Rowland, Phd, London School of Hygiene and Tropical Medicine
Publikationer og nyttige links
Generelle publikationer
- Kleinschmidt I, Schwabe C, Shiva M, Segura JL, Sima V, Mabunda SJ, Coleman M. Combining indoor residual spraying and insecticide-treated net interventions. Am J Trop Med Hyg. 2009 Sep;81(3):519-24.
- 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.
- West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Enhanced protection against malaria by indoor residual spraying in addition to insecticide treated nets: is it dependent on transmission intensity or net usage? PLoS One. 2015 Mar 26;10(3):e0115661. doi: 10.1371/journal.pone.0115661. eCollection 2015.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ITDCVP54
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-
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