ISRCTN ISRCTN01738840
DOI https://doi.org/10.1186/ISRCTN01738840
Secondary identifying numbers SCC Number 1128, Version 1.0, 17th March 2010
Submission date
27/08/2010
Registration date
19/10/2010
Last edited
08/08/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Steve Lindsay
Scientific

Department of Disease Control
London School of Hygiene & Tropical Medicine
London
WC1E 7HT
United Kingdom

Phone +44 (0)20 7927 2674
Email Steve.Lindsay@lshtm.ac.uk

Study information

Study designTwo-armed cluster-randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCan 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
Study acronymSANTE
Study objectivesTo 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(s)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)
Health condition(s) or problem(s) studiedMalaria morbidity and infection
Intervention1. 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 typeOther
Primary outcome measureIncidence 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 measures1. 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 study start date01/03/2010
Completion date30/04/2012

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit13 Years
SexBoth
Target number of participantsApproximately 7,700 children
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment01/03/2010
Date of final enrolment30/04/2012

Locations

Countries of recruitment

  • England
  • Gambia
  • United Kingdom

Study participating centre

Department of Disease Control
London
WC1E 7HT
United Kingdom

Sponsor information

Medical Research Council Laboratories (Gambia)
Research council

Atlantic Road
PO Box 273 Banju
Fajara
-
Gambia

Phone (+220) 449 5442/6 ext. 2308
Email scc@mrc.gm
Website http://www.mrc.gm/
ROR logo "ROR" https://ror.org/025wfj672

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: SSC 1128)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/06/2011 Yes No
Results article results 11/04/2015 Yes No
Results article results 06/08/2018 Yes No

Editorial Notes

08/08/2018: Publication reference added.