MalariaSMCNCT02646410
Optimization of Seasonal Malaria Chemoprevention (SMC) Delivery
A study testing FPD+NDOT, FPD+DOT and DDD+NDOT in people with Malaria and Anemia, run by University of Bamako at 1 site in Mali.
Trial summary
Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy for malaria control in countries with seasonal malaria transmission such as Mali in March 2012. Read more about this study
- Who is it for?
- Ages 3 to 59 monthsHealthy volunteers can take part
- What is being tested?
- FPD+NDOT, FPD+DOT and DDD+NDOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteMali
- Study dates
- Aug 2014to Dec 2018
- Phase
- Interventional
- 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 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age >= 3 months \& < 60 months
Who cannot join
- severe, chronic illness
- known allergy to one of the study drugs (SP or AQ)
- known HIV positive subjects using Cotrimoxazole.
Trial locations and contacts
1 site in 1 country.
Alassane Dicko, MD contact
Amadou Barry, MD contact
About this study
Official title: Optimal Delivery of Seasonal Malaria Chemoprevention and Its Effects on the Acquisition of Malaria Immunity
Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy for malaria control in countries with seasonal malaria transmission such as Mali in March 2012. The goals are to identify the most effective method to deliver SMC, and to obtain more information on the long term impact of SMC on malaria immunity. Our specific aims are 1) to determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs non-DOT (NDOT)) and frequency (3 vs 4 doses per season) of SMC delivery; 2) to compare quantitative measures of immunity in children who do and do not receive SMC. A cluster-randomized design will be sued. The target population will be children aged 3-59 months old in Ouelessebougou district, Mali. In Year 1, villages in four sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT). The optimal mode of delivery will be selected based on the SMC coverage during the first year, and will then be implemented in villages of two additional sub-districts. Villages in these two newly selected sub-districts will be randomized in two groups. Children in the first group will received three rounds of SMC and those in the second group will receive four rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of clinical malaria as measured by passive surveillance. In Year 3, children in the selected sub-districts will received SMC by the optimal delivery system determined in Years 1 -2. A survey will be conducted collect data on mortality and hospital admission and compare these outcomes in areas where SMC was implemented and areas where SMC was not implemented.
Read the detailed description
Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy for malaria control in countries with seasonal malaria transmission such as Mali in March 2012. The strategy is a highly cost-effective approach to reduce childhood mortality in these areas. Despite the huge benefit of the SMC on malaria infection and disease, the optimal approach to deliver SMC remains to be determined and there is no data on the long term effect of this strategy on the development of immunity to malaria. While fixed-point delivery (FPD) combined with non directly observed treatment (NDOT) by community health workers is attractive for the SMC implementation, it is need to be evaluated and compared to other mode of delivery. The objectives are to identify the most effective method to deliver SMC, and to obtain information on the long term impact of SMC on malaria immunity. Specifically, i) to determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs. non-DOT (NDOT)) and frequency (3 vs. 4 doses per season) of SMC delivery; ii) to compare quantitative measures of immunity in children who do and do not receive SMC over a three year period.
The design is a cluster-randomized trial over three years. The target population is children aged 3-59 months old living in Ouelessebougou district, Mali. In Year 1, villages in four sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT). The optimal mode of delivery will be selected based on the SMC coverage during the first year, and will then be implemented in villages of two additional sub-districts. Villages in these two newly selected sub-districts will be randomized in two groups. Children in the first group will received three rounds of SMC and those in the second group will receive four rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of clinical malaria as measured by passive surveillance. Children in the four sub-districts selected in Year 1 will continue to receive three rounds of SMC in Year 2 using the optimal mode of delivery. In Year 3, children in the randomly selected sub-districts will received SMC by the optimal delivery system determined in Years 1 -2. Immune responses will be measured and compared between the children receiving SMC to a cohort of children not receiving SMC, to assess the impact of SMC on key antimalarial antibody responses over the three year period using cross-sectional surveys at the beginning and the end of the transmission season.
In Year 3, 4 and 5 surveys will be conducted to collect data on mortality and hospital admissions and compare these outcomes in areas where SMC was implemented and areas where SMC was not implemented.
- Being tested
- FPD+NDOT, FPD+DOT, DDD+NDOT, DDD+DOT
- Keywords
- malaria, seasonal malaria chemoprevention, immunity, resistance, sulfadoxine-pyrimethamine, amodiaquine, delivery method
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPD+NDOTOther
Also called fixed-point delivery + non directly observed treatment
FPD+DOTOther
Also called fixed-point delivery + directly observed treatment
DDD+NDOTOther
Door to door delivery + non directly observed treatment
DDD+DOTOther
Door to door delivery + directly observed treatment
| Study group | Role | What they receive |
|---|---|---|
| FPD+NDOT | Other | Fixed-point delivery (FPD) combined with non directly observed treatment (NDOT) Receives: Other: FPD+NDOT |
| FPD+DOT | Other | Fixed-point delivery (FPD) combined with directly observed treatment (DOT) Receives: Other: FPD+DOT |
| DDD+NDOT | Other | door-to-door delivery (DDD) combined with non directly observed treatment (NDOT) Receives: Other: DDD+NDOT |
| DDD+DOT | Other | door-to-door delivery (DDD) combined with directly observed treatment (NDOT) Receives: Other: DDD+DOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coverage of SMC
SMC coverage will be defined as proportion of the children who have received the three treatments doses at each of the three rounds of SMC.
Measured: 1-5 weeks after last round of SMC in Year1
Incidence of clinical malaria in Year 2
Clinical malaria defined as signs and symptoms suggestive of malaria with positive RDT and/or positive blood smear.
Measured: up to 4 weeks after the last round of SMC
Mortality rate
death
Measured: 1, 2, 3, 4 years of the intervention
Hospital admission
Hospitalization
Measured: 1, 2, 3, 4 years of the intervention
Secondary outcomes (6)
malaria parasitemia
Parasite prevalence defined as the proportion of children with a positive malaria blood smear and parasite density
Measured: one week before the first round of SMC and 4-6 weeks after the last round of SMC
moderate anemia
Prevalence of moderate anemia defined as hemoglobin concentration < 8 g/dL measured by hemoglobin analyzer
Measured: one week before the first round of SMC and 4-6 weeks after the last round of SMC
immune response to malaria parasite
Cellular and humoral antimalarial immune responses to malaria parasites
Measured: one week before the first round of SMC and 4-6 weeks after the last round of SMC
molecular markers of resistance to SP + AQ
Frequency of mutations at codons 51, 59, and 108 of the dhfr gene, 437 and 540 of the dhps gene, codon 76 in the P. falciparum chloroquine transporter gene (pfcrt), and codon 86 of the P. falciparum multidrug resistance gene one (pfmdr1).
Measured: one week before the first round of SMC and 4-6 weeks after the last round of SMC
nutritional status
Prevalence of wasting stunting and underweight as defined by WHO Global database on Child Growth and Malnutrition
Measured: one week before the first round of SMC and 4-6 weeks after the last round of SMC
Clinical malaria in Year 1
Clinical malaria defined as signs and symptoms suggestive of malaria with positive RDT and/or positive blood smear.
Measured: up to 4 weeks after the last round of SMC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bamako
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alassane Dicko, University of Bamako
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646410
- Sponsor's protocol ID
- 2014-61
- Acronym
- SMC
- Status last verified
- Apr 2018
- First submitted
- 29 Dec 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Issiaka D, Barry A, Traore T, Diarra B, Cook D, Keita M, Sagara I, Duffy P, Fried M, Dicko A. Impact of seasonal malaria chemoprevention on hospital admissions and mortality in children under 5 years of age in Ouelessebougou, Mali. Malar J. 2020 Mar 3;19(1):103. doi: 10.1186/s12936-020-03175-y.
PubMed 32126989Barry A, Issiaka D, Traore T, Mahamar A, Diarra B, Sagara I, Kone D, Doumbo OK, Duffy P, Fried M, Dicko A. Optimal mode for delivery of seasonal malaria chemoprevention in Ouelessebougou, Mali: A cluster randomized trial. PLoS One. 2018 Mar 5;13(3):e0193296. doi: 10.1371/journal.pone.0193296. eCollection 2018.
PubMed 29505578
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Delivery of Seasonal Malaria Chemoprevention and Its Effects on the Acquisition of Malaria Immunity
- ClinicalTrials.gov ID
- NCT02646410
- Acronym / sponsor ID
- SMC / 2014-61
- Keywords
- malaria, seasonal malaria chemoprevention, immunity, resistance, sulfadoxine-pyrimethamine, amodiaquine, delivery method
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of BamakoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Jan 2016 (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.
Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy for malaria control in countries with seasonal malaria transmission such as Mali in March 2012. The goals are to identify the most effective method to deliver SMC, and to obtain more information on the long term impact of SMC on malaria immunity. Our specific aims are 1) to determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs non-DOT (NDOT)) and frequency (3 vs 4 doses per season) of SMC delivery; 2) to compare quantitative measures of immunity in children who do and do not receive SMC. A cluster-randomized design will be sued. The target population will be children aged 3-59 months old in Ouelessebougou district, Mali. In Year 1, villages in four sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT). The optimal mode of delivery will be selected based on the SMC coverage during the first year, and will then be implemented in villages of two additional sub-districts. Villages in these two newly selected sub-districts will be randomized in two groups. Children in the first group will received three rounds of SMC and those in the second group will receive four rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of clinical malaria as measured by passive surveillance. In Year 3, children in the selected sub-districts will received SMC by the optimal delivery system determined in Years 1 -2. A survey will be conducted collect data on mortality and hospital admission and compare these outcomes in areas where SMC was implemented and areas where SMC was not implemented.
Detailed description
Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy for malaria control in countries with seasonal malaria transmission such as Mali in March 2012. The strategy is a highly cost-effective approach to reduce childhood mortality in these areas. Despite the huge benefit of the SMC on malaria infection and disease, the optimal approach to deliver SMC remains to be determined and there is no data on the long term effect of this strategy on the development of immunity to malaria. While fixed-point delivery (FPD) combined with non directly observed treatment (NDOT) by community health workers is attractive for the SMC implementation, it is need to be evaluated and compared to other mode of delivery. The objectives are to identify the most effective method to deliver SMC, and to obtain information on the long term impact of SMC on malaria immunity. Specifically, i) to determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs. non-DOT (NDOT)) and frequency (3 vs. 4 doses per season) of SMC delivery; ii) to compare quantitative measures of immunity in children who do and do not receive SMC over a three year period.
The design is a cluster-randomized trial over three years. The target population is children aged 3-59 months old living in Ouelessebougou district, Mali. In Year 1, villages in four sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT). The optimal mode of delivery will be selected based on the SMC coverage during the first year, and will then be implemented in villages of two additional sub-districts. Villages in these two newly selected sub-districts will be randomized in two groups. Children in the first group will received three rounds of SMC and those in the second group will receive four rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of clinical malaria as measured by passive surveillance. Children in the four sub-districts selected in Year 1 will continue to receive three rounds of SMC in Year 2 using the optimal mode of delivery. In Year 3, children in the randomly selected sub-districts will received SMC by the optimal delivery system determined in Years 1 -2. Immune responses will be measured and compared between the children receiving SMC to a cohort of children not receiving SMC, to assess the impact of SMC on key antimalarial antibody responses over the three year period using cross-sectional surveys at the beginning and the end of the transmission season.
In Year 3, 4 and 5 surveys will be conducted to collect data on mortality and hospital admissions and compare these outcomes in areas where SMC was implemented and areas where SMC was not implemented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FPD+NDOT | Other | Other: FPD+NDOTFixed-point delivery (FPD) combined with non directly observed treatment (NDOT) |
| FPD+DOT | Other | Other: FPD+DOTFixed-point delivery (FPD) combined with directly observed treatment (DOT) |
| DDD+NDOT | Other | Other: DDD+NDOTdoor-to-door delivery (DDD) combined with non directly observed treatment (NDOT) |
| DDD+DOT | Other | Other: DDD+DOTdoor-to-door delivery (DDD) combined with directly observed treatment (NDOT) |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age >= 3 months \& < 60 months
Key exclusion criteria (3 listed)
- severe, chronic illness
- known allergy to one of the study drugs (SP or AQ)
- known HIV positive subjects using Cotrimoxazole.
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 |
|---|---|---|
| FPD+NDOTAlso: fixed-point delivery + non directly observed treatment | Other | FPD+NDOT |
| FPD+DOTAlso: fixed-point delivery + directly observed treatment | Other | FPD+DOT |
| DDD+NDOTDoor to door delivery + non directly observed treatment | Other | DDD+NDOT |
| DDD+DOTDoor to door delivery + directly observed treatment | Other | DDD+DOT |
Primary outcome
Coverage of SMC
Time frame: 1-5 weeks after last round of SMC in Year1
SMC coverage will be defined as proportion of the children who have received the three treatments doses at each of the three rounds of SMC.
Incidence of clinical malaria in Year 2
Time frame: up to 4 weeks after the last round of SMC
Clinical malaria defined as signs and symptoms suggestive of malaria with positive RDT and/or positive blood smear.
Mortality rate
Time frame: 1, 2, 3, 4 years of the intervention
death
Hospital admission
Time frame: 1, 2, 3, 4 years of the intervention
Hospitalization
6 secondary outcomes
malaria parasitemia
Time frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC
moderate anemia
Time frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC
immune response to malaria parasite
Time frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC
molecular markers of resistance to SP + AQ
Time frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC
nutritional status
Time frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC
Clinical malaria in Year 1
Time frame: up to 4 weeks after the last round of SMC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 32126989Issiaka D, Barry A, Traore T, Diarra B, Cook D, Keita M, Sagara I, Duffy P, Fried M, Dicko A. Impact of seasonal malaria chemoprevention on hospital admissions and mortality in children under 5 years of age in Ouelessebougou, Mali. Malar J. 2020 Mar 3;19(1):103. doi: 10.1186/s12936-020-03175-y.
- Derived from this study: PubMed 29505578Barry A, Issiaka D, Traore T, Mahamar A, Diarra B, Sagara I, Kone D, Doumbo OK, Duffy P, Fried M, Dicko A. Optimal mode for delivery of seasonal malaria chemoprevention in Ouelessebougou, Mali: A cluster randomized trial. PLoS One. 2018 Mar 5;13(3):e0193296. doi: 10.1371/journal.pone.0193296. eCollection 2018.
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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.
Alassane Dicko, MD contact
Amadou Barry, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPD+NDOT, FPD+DOT and DDD+NDOT in people with Malaria and Anemia, run by University of Bamako at 1 site in Mali.
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 1 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Alassane Dicko, MD (adicko@icermali.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coverage of SMC (time frame: 1-5 weeks after last round of SMC in Year1). The study lists 4 primary outcomes in all. 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 NCT02646410, which also lists 2 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 2 May 2018.