Association Between Drug Levels, Malaria, and Antimalarial Resistance in the Setting of Seasonal Malaria Chemoprevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-16

Study Completion Date

2023-05-23

Brief Summary

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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.

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Detailed Description

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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:

1. To determine associations between the levels of exposure to the components of SP+AQ (SDX, PYR, and AQ) and malaria risk.
2. 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.
3. 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.
4. To assess whether the prevalence of genetic polymorphisms associated with SP+AQ resistance changes over time.

Conditions

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Malaria,Falciparum

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* Aged 6-59 months
* Resident of health facility catchment area
* Provision of parental consent
* Negative for P. falciparum parasitemia by RDT and/or microscopy

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

6 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No