Spraying And Nets Towards malaria Elimination
| ISRCTN | ISRCTN01738840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01738840 |
| Protocol serial number | SCC Number 1128, Version 1.0, 17th March 2010 |
| Sponsor | Medical Research Council Laboratories (Gambia) |
| Funder | Medical Research Council (MRC) (UK) (ref: SSC 1128) |
- 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
Scientific
Department of Disease Control
London School of Hygiene & Tropical Medicine
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7927 2674 |
|---|---|
| Steve.Lindsay@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-armed cluster-randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | SANTE |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Mean haemoglobin concentration in children in the two study arms measured in the end of the transmission season survey |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 13 Years |
| Sex | All |
| Target sample size at registration | 7700 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
- Gambia
Study participating centre
Department of Disease Control
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/08/2018: Publication reference added.
