Malaria,FalciparumDRUMARSNCT04969185
Association Between Drug Levels, Malaria, and Antimalarial Resistance in the Setting of Seasonal Malaria Chemoprevention
An observational study of Malaria,Falciparum, run by University of California, San Francisco at 2 sites in Burkina Faso.
Trial summary
In areas of the Sahel sub-region of Africa with intense seasonal malaria transmission, seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine (SP+AQ) has become the standard-of-care for the prevention of malaria in children. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Malaria,Falciparum
- How many people
- 310 participants
- Where
- 2 sitesBurkina Faso
- Study dates
- 16 Aug 2021to 23 May 2023
- Phase
- Observational
- 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 6 months to 10 years
- All sexes
- Child
Study population: The target population will be children residing in the catchment areas of study health facilities within Bobo-Dioulasso, Burkina Faso.
The inclusion criteria will differ for each group enrolled into the study:
Inclusion criteria for Group 1 (Children 6-59 months of age diagnosed with uncomplicated P. falciparum malaria):
- Aged 6-59 months
- Resident of health facility catchment area
- Provision of parental consent
- Fever (temperature of ≥37.5°C) or history of fever in the past 24 hours
- Confirmed P. falciparum parasitemia by RDT and/or microscopy
Inclusion criteria for Group 2 (Children 6-59 months of age without malaria):
- Aged 6-59 months
- Resident of health facility catchment area
- Provision of parental consent
- Negative for P. falciparum parasitemia by RDT and/or microscopy
Inclusion criteria for Group 3 (Children 5-10 years of age diagnosed with uncomplicated P. falciparum malaria):
- Aged 5-10 years
- Resident of health facility catchment area
- Provision of parental consent
- Fever (temperature of ≥37.5°C) or history of fever in the past 24 hours
- Confirmed P. falciparum parasitemia by RDT and/or microscopy
The exclusion criteria for all children are as follows:
- Refusal to participate
- Residence outside of health facility catchment areas
- Known treatment of malaria (not SMC) in the past 14 days
- Danger signs (lethargy, unable to drink or breast feed, repeated vomiting, unable to stand or sit due to weakness)
- Signs of severe malaria, including altered conscious, respiratory distress (rapid breathing), severe anemia (<5 g/dL), or other signs of organ dysfunction.
- Non-malarial illness that is severe or prevents necessary study procedures
Trial locations and contacts
2 sites in 1 country.
Burkina Faso2 sites
Colsama Health Facility
Bobo-Dioulasso
Sakaby Health Facility
Bobo-Dioulasso
About this study
Official title: Associations Between Drug Levels and the Risk of Malaria and Drug Resistance in the Setting of Seasonal Malaria Chemoprevention in Bobo-Dioulasso, Burkina Faso
In areas of the Sahel sub-region of Africa with intense seasonal malaria transmission, seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine (SP+AQ) has become the standard-of-care for the prevention of malaria in children. Despite the scale-up of SMC across West Africa, the malaria burden remains high. Reasons for this are not well understood, however, it is hypothesized that children eligible for SMC who get malaria may be underdosed or may have not received SP+AQ. Moreover, there are major concerns that the continued use of the SMC strategy may increase selection of AQ and/or SP-resistant Plasmodium falciparum parasites. The overall objective of this observational study are to understand the factors driving malaria among children eligible to receive SMC and whether circulating levels of sulfadoxine (SDX), pyrimethamine (PYR), and AQ are associated with risks of malaria and antimalarial drug resistance.
Read the detailed description
In areas of the Sahel sub-region of Africa with intense seasonal malaria transmission, seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine (SP+AQ) has become the standard-of-care for the prevention of malaria in children. Despite the scale-up of SMC across West Africa, the malaria burden remains high. Reasons for this are not well understood, however, it is hypothesized that children eligible for SMC who get malaria may be underdosed or may have not received SP+AQ. Moreover, there are major concerns that the continued use of the SMC strategy may increase selection of AQ and/or SP-resistant Plasmodium falciparum parasites. The overall objective of this observational study are to understand the factors driving malaria among children eligible to receive SMC and whether circulating levels of sulfadoxine (SDX), pyrimethamine (PYR), and AQ are associated with risks of malaria and antimalarial drug resistance. The specific objectives of this study are as follows:
- To determine associations between the levels of exposure to the components of SP+AQ (SDX, PYR, and AQ) and malaria risk.
- To determine associations between levels of exposure to the components of SP+AQ and the prevalence of P. falciparum genetic polymorphisms associated with drug resistance.
- To compare the prevalence of genetic polymorphisms associated with SP+AQ resistance between parasites infecting children eligible to receive SMC and those infecting older children ineligible to receive SMC.
- To assess whether the prevalence of genetic polymorphisms associated with SP+AQ resistance changes over time.
- Conditions
- Malaria,Falciparum
- Keywords
- seasonal malaria chemoprevention, sulfadoxine-pyrimethamine, amodiaquine, antimalarial resistance, pharmacokinetics, falciparum malaria, malnutrition
- Medical subject headings
- Malaria, Falciparum, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Children eligible to receive SMC diagnosed with uncomplicated Plasmodium falciparum malaria | Children eligible to receive SMC (6-59 months of age) who were diagnosed with uncomplicated P. falciparum malaria at the health facility. | |
| Group 2: Children eligible to receive SMC presenting at health facility without malaria parasitemia | Group 2 will be defined as children eligible to receive SMC (6-59 months of age) who presented at the health facility and tested negative for malaria parasitemia.This group will serve as the control group to Group 1 Cases to compare the SP-AQ drug levels between children who did and did not get malaria. | |
| Group 3: Children 5-10 years of age diagnosed with uncomplicated Plasmodium falciparum malaria | Group 3 will be defined as children ineligible to receive SMC (5-10 years of age) who were diagnosed with uncomplicated P. falciparum malaria at the health facility. This group will serve as the control group to Group 1 Cases to compare the prevalence of SP and AQ resistance markers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of parasitemia
Detected by blood smear microscopy
Measured: during the seasonal SMC campaign period over three years
Prevalence of antimalarial resistance markers associated with SP
Prevalence of pfdhfr and pfdhps mutations
Measured: during the seasonal SMC campaign period over three years
Prevalence of antimalarial resistance markers associated with AQ
Prevalence of pfcrt and pfmdr1 mutations
Measured: during the seasonal SMC campaign period over three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start16 Aug 2021
- Primary completion30 Nov 2021
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Philip Rosenthal, MD, Principal investigator, University of California, San FranciscoJean-Bosco Ouédraogo, MD PhD, Principal investigator, Institut de Recherche en Sciences de la Santé, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969185
- Sponsor's protocol ID
- 21-33890
- Acronym
- DRUMARS
- Status last verified
- Aug 2023
- First submitted
- 9 Jul 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roh ME, Zongo I, Haro A, Huang L, Some AF, Yerbanga RS, Conrad MD, Wallender E, Legac J, Aweeka F, Ouedraogo JB, Rosenthal PJ. Seasonal Malaria Chemoprevention Drug Levels and Drug Resistance Markers in Children With or Without Malaria in Burkina Faso: A Case-Control Study. J Infect Dis. 2023 Oct 3;228(7):926-935. doi: 10.1093/infdis/jiad172.
PubMed 37221018
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Drug Levels and the Risk of Malaria and Drug Resistance in the Setting of Seasonal Malaria Chemoprevention in Bobo-Dioulasso, Burkina Faso
- ClinicalTrials.gov ID
- NCT04969185
- Acronym / sponsor ID
- DRUMARS / 21-33890
- Conditions
- Malaria,Falciparum
- Keywords
- seasonal malaria chemoprevention, sulfadoxine-pyrimethamine, amodiaquine, antimalarial resistance, pharmacokinetics, falciparum malaria, malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 20 Jul 2021 (actual)
- 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 the Sahel sub-region of Africa with intense seasonal malaria transmission, seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine (SP+AQ) has become the standard-of-care for the prevention of malaria in children. Despite the scale-up of SMC across West Africa, the malaria burden remains high. Reasons for this are not well understood, however, it is hypothesized that children eligible for SMC who get malaria may be underdosed or may have not received SP+AQ. Moreover, there are major concerns that the continued use of the SMC strategy may increase selection of AQ and/or SP-resistant Plasmodium falciparum parasites. The overall objective of this observational study are to understand the factors driving malaria among children eligible to receive SMC and whether circulating levels of sulfadoxine (SDX), pyrimethamine (PYR), and AQ are associated with risks of malaria and antimalarial drug resistance.
Detailed description
In areas of the Sahel sub-region of Africa with intense seasonal malaria transmission, seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine (SP+AQ) has become the standard-of-care for the prevention of malaria in children. Despite the scale-up of SMC across West Africa, the malaria burden remains high. Reasons for this are not well understood, however, it is hypothesized that children eligible for SMC who get malaria may be underdosed or may have not received SP+AQ. Moreover, there are major concerns that the continued use of the SMC strategy may increase selection of AQ and/or SP-resistant Plasmodium falciparum parasites. The overall objective of this observational study are to understand the factors driving malaria among children eligible to receive SMC and whether circulating levels of sulfadoxine (SDX), pyrimethamine (PYR), and AQ are associated with risks of malaria and antimalarial drug resistance. The specific objectives of this study are as follows:
- To determine associations between the levels of exposure to the components of SP+AQ (SDX, PYR, and AQ) and malaria risk.
- To determine associations between levels of exposure to the components of SP+AQ and the prevalence of P. falciparum genetic polymorphisms associated with drug resistance.
- To compare the prevalence of genetic polymorphisms associated with SP+AQ resistance between parasites infecting children eligible to receive SMC and those infecting older children ineligible to receive SMC.
- To assess whether the prevalence of genetic polymorphisms associated with SP+AQ resistance changes over time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Children eligible to receive SMC diagnosed with uncomplicated Plasmodium falciparum malaria | – | –Children eligible to receive SMC (6-59 months of age) who were diagnosed with uncomplicated P. falciparum malaria at the health facility. |
| Group 2: Children eligible to receive SMC presenting at health facility without malaria parasitemia | – | –Group 2 will be defined as children eligible to receive SMC (6-59 months of age) who presented at the health facility and tested negative for malaria parasitemia.This group will serve as the control group to Group 1 Cases to compare the SP-AQ drug levels between children who did and did not get malaria. |
| Group 3: Children 5-10 years of age diagnosed with uncomplicated Plasmodium falciparum malaria | – | –Group 3 will be defined as children ineligible to receive SMC (5-10 years of age) who were diagnosed with uncomplicated P. falciparum malaria at the health facility. This group will serve as the control group to Group 1 Cases to compare the prevalence of SP and AQ resistance markers. |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- The target population will be children residing in the catchment areas of study health facilities within Bobo-Dioulasso, Burkina Faso.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk of parasitemia
Time frame: during the seasonal SMC campaign period over three years
Detected by blood smear microscopy
Prevalence of antimalarial resistance markers associated with SP
Time frame: during the seasonal SMC campaign period over three years
Prevalence of pfdhfr and pfdhps mutations
Prevalence of antimalarial resistance markers associated with AQ
Time frame: during the seasonal SMC campaign period over three years
Prevalence of pfcrt and pfmdr1 mutations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Results publication: PubMed 37221018Roh ME, Zongo I, Haro A, Huang L, Some AF, Yerbanga RS, Conrad MD, Wallender E, Legac J, Aweeka F, Ouedraogo JB, Rosenthal PJ. Seasonal Malaria Chemoprevention Drug Levels and Drug Resistance Markers in Children With or Without Malaria in Burkina Faso: A Case-Control Study. J Infect Dis. 2023 Oct 3;228(7):926-935. doi: 10.1093/infdis/jiad172.
- Individual participant dataSharing planned: No
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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.
Philip Rosenthal, MD principal investigator
University of California, San Francisco
Jean-Bosco Ouédraogo, MD PhD principal investigator
Institut de Recherche en Sciences de la Santé, Burkina Faso
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria,Falciparum, run by University of California, San Francisco at 2 sites in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Risk of parasitemia (time frame: during the seasonal SMC campaign period over three years). The study lists 3 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 NCT04969185, which also lists 1 linked publication.
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 14 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.