Condition category
Infections and Infestations
Date applied
27/08/2010
Date assigned
19/10/2010
Last edited
13/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mrc.gm/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: SSC 1128)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

  2. 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.

Additional files

Editorial Notes