Contact information
Type
Scientific
Primary contact
Prof Steve Lindsay
ORCID ID
Contact details
Department of Disease Control
London School of Hygiene & Tropical Medicine
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2674
Steve.Lindsay@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SCC Number 1128, Version 1.0, 17th March 2010
Study information
Scientific title
Can indoor residual spraying provide additional protection against clinical malaria over current best practice of long-lasting insecticide impregnated nets? A cluster-randomised controlled trial in children in The Gambia
Acronym
SANTE
Study hypothesis
To evaluate whether there is any benefit against malaria from using indoor residual spraying and long-lasting impregnated nets (LLINs) combined compared to LLINs alone.
Ethics approval
1. Gambia Government/MRC Laboratories Joint Ethics Committee first approved on the 12th August 2008 (ref: L2009.15, L2010.19; SCC1128)
2. LSHTM Ethics Committee approved on the 16th September 2009 (ref: 5592)
Study design
Two-armed cluster-randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malaria morbidity and infection
Intervention
1. DDT indoor residual spraying: with rooms sprayed with DDT (2 g/m2), in May/June, at the start of the main malaria transmission season, in 2010 and 2011.
2. Long-lasting insecticidal nets (LLINs): Olyset, permethrin, 2% w/w on polyethylene netting, Sumitomo Chemicals.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence of clinical episodes of malaria presenting at health facilities defined as a child with an axillary temperature of greater than or equal to 37.5°C or a history of fever in the past 48 hours, together with the presence of P. falciparum parasites of any density detected by microscopy and/or RDT in the absence of other detectable cause of fever.
Secondary outcome measures
1. Mean haemoglobin concentration in children in the two study arms measured in the end of the transmission season survey
2. Parasite prevalence in children in the two study arms measured at the end of the transmission season
Overall trial start date
01/03/2010
Overall trial end date
30/04/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. No distinctions will be made regarding gender or ethnic group
2. Children (aged 6 months - 13 years old) whose parents/carers give written, informed consent for their child
3. Eligible children greater than 6 years old will also be explained the purpose of the study and what is required according to their capability
4. In the case of school age children, only those who live in their village during term-time
In order for the results from this study to be as generalisable as possible, no distinctions will be made in terms of medical condition or physical health.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Approximately 7,700 children
Participant exclusion criteria
1. Children for whom informed consent is not or cannot be provided
2. Aged under 6 months or over 13 years on 1st June for the year of survey
3. Expected to be non-residence during several months of the transmission season
Recruitment start date
01/03/2010
Recruitment end date
30/04/2012
Locations
Countries of recruitment
Gambia
Trial participating centre
Department of Disease Control
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council Laboratories (Gambia)
Sponsor details
Atlantic Road
PO Box 273 Banju
Fajara
-
Gambia
(+220)449 5442/6 ext. 2308
scc@mrc.gm
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: SSC 1128)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21663656
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25498847
Publication citations
-
Results
Pinder M, Jawara M, Jarju LB, Kandeh B, Jeffries D, Lluberas MF, Mueller J, Parker D, Bojang K, Conway DJ, Lindsay SW, To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial., Trials, 2011, 12, 147, doi: 10.1186/1745-6215-12-147.
-
Results
Pinder M, Jawara M, Jarju LB, Salami K, Jeffries D, Adiamoh M, Bojang K, Correa S, Kandeh B, Kaur H, Conway DJ, D'Alessandro U, Lindsay SW, Efficacy of indoor residual spraying with dichlorodiphenyltrichloroethane against malaria in Gambian communities with high usage of long-lasting insecticidal mosquito nets: a cluster-randomised controlled trial, Lancet, 2014, doi: 10.1016/S0140-6736(14)61007-2.