MalariaPhase 4NCT00712374
Evaluation of the Public Health Impact of Seasonal Intermittent Preventive Treatment (IPT) in Children in Senegal
A Phase 4 study testing sulfadoxine-pyrimethamine plus amodiaquine in people with Malaria, run by London School of Hygiene and Tropical Medicine.
Trial summary
In areas of seasonal malaria transmission the burden of severe disease and mortality due to malaria is mainly among children under 5 years of age. Intermittent preventive treatment (IPT) with antimalarial drugs given to all children once a month during the transmission season is a promising new strategy for malaria… Read more about this study
- Who is it for?
- Ages 3 to 119 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- sulfadoxine-pyrimethamine plus amodiaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 119 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 3-119 months at time of first administration of IPT in September
- Consent of mother or carer and the local community
Who cannot join
- History of allergy to SP or AQ
- Age < 3 months or >119 months at time of first administration of IPT in September
- From 2009, the age for inclusion has been changed from 3-59 months to 3 months to 10 years of age.
About this study
Official title: Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal
In areas of seasonal malaria transmission the burden of severe disease and mortality due to malaria is mainly among children under 5 years of age. Intermittent preventive treatment (IPT) with antimalarial drugs given to all children once a month during the transmission season is a promising new strategy for malaria prevention. Studies in Senegal, Ghana, Mali and The Gambia have shown this approach can be highly effective. In Senegal, seasonal IPT with sulfadoxine-pyrimethamine (SP) and one dose of artesunate resulted in a 90% reduction in incidence of clinical malaria in a recent trial in Senegal (Cisse et al., Lancet 2006). The purpose of the present project is to determine the public health impact and cost effectiveness of this intervention when it is delivered through the routine health service to communities in rural areas in Senegal. Demographic surveillance will be set up in the rural population of three districts (Mbour, Bambey and Fatick) which comprises approximately 540,000 people, including 100,000 children under 5 yrs, and is served by 54 health posts, as an expansion of the area covered by the existing DSS of Niakhar. Information about births, deaths and migrations, household characteristics such as socioeconomic status, and vaccination status of children and their use of bednets, will be recorded in 6-monthly rounds of all households. In selected areas, deaths among children under 10 years will be investigated using verbal autopsies. Over four years from September 2008 - November 2011, seasonal IPT (three monthly administrations of SP (sulfalene-pyrimethamine) plus amodiaquine during the transmission season each year to children 3-59 months of age) will be introduced gradually, in a step-wedge design, by 9 health posts in 2008, by an additional 18 posts in 2009, and another 18 in 2010 and 9 in 2011. At the end of each transmission season, a cross-sectional survey of 2400 children under 5 yrs of age, in which finger prick blood samples will be taken, will be used to estimate the prevalence of molecular markers of drug resistance to Plasmodium falciparum, the prevalence of anaemia and the nutritional status of children. Malaria incidence will be monitored by passive surveillance through health posts, health centres, and hospitals. Cost effectiveness will be assessed. Due to changes in the epidemiology of malaria in the study area, the upper age limit for inclusion was increased from 5 to 10 years old from September 2009.
- Conditions
- Malaria
- Being tested
- sulfadoxine-pyrimethamine plus amodiaquine
- Keywords
- Malaria, All causes mortality, Cost effectiveness
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulfadoxine-pyrimethamine plus amodiaquineDrug
SP+AQ on three occasions during the malaria transmission season
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Children 3 months to 10 years old will receive a treatment dose of SP+AQ on three occasions during the malaria transmission season, delivered by the local health post Receives: Drug: sulfadoxine-pyrimethamine plus amodiaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-causes mortality
Measured: 2008-2010
Secondary outcomes (1)
Incidence of malaria by passive case detection
Measured: 2008-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2011 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Senegal: Ministere de la Sante, Institut de Recherche pour le Developpement, Cheikh Anta Diop University, Senegal
- Investigators
- Oumar Gaye, PhD, Study director, Universite CHeikh Anta DiopBadara Cisse, PhD, Principal investigator, London School of Hygiene and Tropical MedicineCheikh Sokhna, PhD, Principal investigator, IRD, DakarOumar Faye, MD, Principal investigator, Ministere de la Sante et de la PreventionPaul Milligan, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712374
- Sponsor's protocol ID
- PSP01
- Other IDs
- 40099
- Status last verified
- Sep 2009
- First submitted
- 8 Jul 2008
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dieng S, Ba EH, Cisse B, Sallah K, Guindo A, Ouedraogo B, Piarroux M, Rebaudet S, Piarroux R, Landier J, Sokhna C, Gaudart J. Spatio-temporal variation of malaria hotspots in Central Senegal, 2008-2012. BMC Infect Dis. 2020 Jun 17;20(1):424. doi: 10.1186/s12879-020-05145-w.
PubMed 32552759Cisse B, Ba EH, Sokhna C, NDiaye JL, Gomis JF, Dial Y, Pitt C, NDiaye M, Cairns M, Faye E, NDiaye M, Lo A, Tine R, Faye S, Faye B, Sy O, Konate L, Kouevijdin E, Flach C, Faye O, Trape JF, Sutherland C, Fall FB, Thior PM, Faye OK, Greenwood B, Gaye O, Milligan P. Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial. PLoS Med. 2016 Nov 22;13(11):e1002175. doi: 10.1371/journal.pmed.1002175. eCollection 2016 Nov.
PubMed 27875528NDiaye JL, Cisse B, Ba EH, Gomis JF, Ndour CT, Molez JF, Fall FB, Sokhna C, Faye B, Kouevijdin E, Niane FK, Cairns M, Trape JF, Rogier C, Gaye O, Greenwood BM, Milligan PJ. Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial. PLoS One. 2016 Oct 20;11(10):e0162563. doi: 10.1371/journal.pone.0162563. eCollection 2016.
PubMed 27764102
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal
- ClinicalTrials.gov ID
- NCT00712374
- Acronym / sponsor ID
- PSP01
- Conditions
- Malaria
- Keywords
- Malaria, All causes mortality, Cost effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Senegal: Ministere de la Sante, Institut de Recherche pour le Developpement, Cheikh Anta Diop University, Senegal
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In areas of seasonal malaria transmission the burden of severe disease and mortality due to malaria is mainly among children under 5 years of age. Intermittent preventive treatment (IPT) with antimalarial drugs given to all children once a month during the transmission season is a promising new strategy for malaria prevention. Studies in Senegal, Ghana, Mali and The Gambia have shown this approach can be highly effective. In Senegal, seasonal IPT with sulfadoxine-pyrimethamine (SP) and one dose of artesunate resulted in a 90% reduction in incidence of clinical malaria in a recent trial in Senegal (Cisse et al., Lancet 2006). The purpose of the present project is to determine the public health impact and cost effectiveness of this intervention when it is delivered through the routine health service to communities in rural areas in Senegal. Demographic surveillance will be set up in the rural population of three districts (Mbour, Bambey and Fatick) which comprises approximately 540,000 people, including 100,000 children under 5 yrs, and is served by 54 health posts, as an expansion of the area covered by the existing DSS of Niakhar. Information about births, deaths and migrations, household characteristics such as socioeconomic status, and vaccination status of children and their use of bednets, will be recorded in 6-monthly rounds of all households. In selected areas, deaths among children under 10 years will be investigated using verbal autopsies. Over four years from September 2008 - November 2011, seasonal IPT (three monthly administrations of SP (sulfalene-pyrimethamine) plus amodiaquine during the transmission season each year to children 3-59 months of age) will be introduced gradually, in a step-wedge design, by 9 health posts in 2008, by an additional 18 posts in 2009, and another 18 in 2010 and 9 in 2011. At the end of each transmission season, a cross-sectional survey of 2400 children under 5 yrs of age, in which finger prick blood samples will be taken, will be used to estimate the prevalence of molecular markers of drug resistance to Plasmodium falciparum, the prevalence of anaemia and the nutritional status of children. Malaria incidence will be monitored by passive surveillance through health posts, health centres, and hospitals. Cost effectiveness will be assessed. Due to changes in the epidemiology of malaria in the study area, the upper age limit for inclusion was increased from 5 to 10 years old from September 2009.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: sulfadoxine-pyrimethamine plus amodiaquineChildren 3 months to 10 years old will receive a treatment dose of SP+AQ on three occasions during the malaria transmission season, delivered by the local health post |
Who may qualify
- Ages
- 3 to 119 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 3-119 months at time of first administration of IPT in September
- Consent of mother or carer and the local community
Key exclusion criteria (3 listed)
- History of allergy to SP or AQ
- Age < 3 months or >119 months at time of first administration of IPT in September
- From 2009, the age for inclusion has been changed from 3-59 months to 3 months to 10 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulfadoxine-pyrimethamine plus amodiaquineSP+AQ on three occasions during the malaria transmission season Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine | Drug | Intervention |
Primary outcome
All-causes mortality
Time frame: 2008-2010
1 secondary outcome
Incidence of malaria by passive case detection
Time frame: 2008-2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
- Derived from this study: PubMed 32552759Dieng S, Ba EH, Cisse B, Sallah K, Guindo A, Ouedraogo B, Piarroux M, Rebaudet S, Piarroux R, Landier J, Sokhna C, Gaudart J. Spatio-temporal variation of malaria hotspots in Central Senegal, 2008-2012. BMC Infect Dis. 2020 Jun 17;20(1):424. doi: 10.1186/s12879-020-05145-w.
- Derived from this study: PubMed 27875528Cisse B, Ba EH, Sokhna C, NDiaye JL, Gomis JF, Dial Y, Pitt C, NDiaye M, Cairns M, Faye E, NDiaye M, Lo A, Tine R, Faye S, Faye B, Sy O, Konate L, Kouevijdin E, Flach C, Faye O, Trape JF, Sutherland C, Fall FB, Thior PM, Faye OK, Greenwood B, Gaye O, Milligan P. Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial. PLoS Med. 2016 Nov 22;13(11):e1002175. doi: 10.1371/journal.pmed.1002175. eCollection 2016 Nov.
- Derived from this study: PubMed 27764102NDiaye JL, Cisse B, Ba EH, Gomis JF, Ndour CT, Molez JF, Fall FB, Sokhna C, Faye B, Kouevijdin E, Niane FK, Cairns M, Trape JF, Rogier C, Gaye O, Greenwood BM, Milligan PJ. Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial. PLoS One. 2016 Oct 20;11(10):e0162563. doi: 10.1371/journal.pone.0162563. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oumar Gaye, PhD study director
Universite CHeikh Anta Diop
Badara Cisse, PhD principal investigator
London School of Hygiene and Tropical Medicine
Cheikh Sokhna, PhD principal investigator
IRD, Dakar
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sulfadoxine-pyrimethamine plus amodiaquine in people with Malaria, run by London School of Hygiene and Tropical Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-causes mortality (time frame: 2008-2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712374, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2009.