Study Results
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Basic Information
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UNKNOWN
PHASE4
800 participants
INTERVENTIONAL
2022-07-15
2023-12-01
Brief Summary
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A Type II hybrid effectiveness-implementation study design will be used to evaluate the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the antimalarial drugs used. The study consists of two components: 1) Conducting a prospective cohort study to determine the protective efficacy of the drug combination Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) (if SPAQ provides 28 days of protection from infection) and whether drug concentrations and/or resistance influence the duration of protection; 2) Conducting a resistance markers study in symptomatic patients in the research district.
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Detailed Description
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The study uses pragmatic implementation research with the objective of contributing to the development of practical recommendations for health policy, practice and potential scale up. It is designed as an implementation study to determine effectiveness and protective efficacy to gather evidence of the potential impact on health outcomes. Five monthly cycles of SMC will be implemented between July and October 2022 in one district, Nanoro, in Centre Ouest region.
The study will comprise the following two components:
1. A prospective protective efficacy cohort study to determine if SPAQ provides 28 days of protection from infection and whether drug concentrations and/or resistance influence the duration of protection
2. A resistance markers study in children 3-59 months in the two research districts plus the two standard intervention districts to measure changes in resistance marker prevalence over time (pre and post within the same year and between years)
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)
Children aged 3-59 months will receive SPAQ during the study period.
Sulfadoxine pyrimethamine
Sulphadoxine is a slowly eliminated sulphonamide. It is used in a fixed dose combination of 20 parts sulphadoxine with 1 part pyrimethamine given orally or intramuscularly.
The medicine is no longer recommended for the treatment of malaria. However, it is being used for Intermittent Preventive Treatment during pregnancy (IPTp) and as a co-packaged combination with amodiaquine for seasonal malaria chemoprevention.
Sulphadoxine is readily absorbed from the GIT. It is widely distributed in body tissues and fluids and crosses the placenta into foetal circulation. It is also readily detectable in breast milk. It is excreted predominantly as the unchanged drug.
Amodiaquine
Amodiaquine is a Mannich base 4 amino-quinoline that interferes with parasite haem detoxification. It is more effective than chloroquine in both chloroquine sensitive and resistant P. falciparum infections. However, there is cross-resistance between chloroquine and amodiaquine.
It is readily absorbed in the GIT and rapidly converted in the liver to the active metabolite, desethylamodiaquine. Desethylamodiaquine is responsible for all the antimalarial effect. Adverse effect of amodiaquine includes abdominal discomfort and vomiting weakness and when used for prophylaxis it causes agranulocytosis. Amodiaquine is recommended as a partner drug in artemisinin based combination therapy.
Interventions
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Sulfadoxine pyrimethamine
Sulphadoxine is a slowly eliminated sulphonamide. It is used in a fixed dose combination of 20 parts sulphadoxine with 1 part pyrimethamine given orally or intramuscularly.
The medicine is no longer recommended for the treatment of malaria. However, it is being used for Intermittent Preventive Treatment during pregnancy (IPTp) and as a co-packaged combination with amodiaquine for seasonal malaria chemoprevention.
Sulphadoxine is readily absorbed from the GIT. It is widely distributed in body tissues and fluids and crosses the placenta into foetal circulation. It is also readily detectable in breast milk. It is excreted predominantly as the unchanged drug.
Amodiaquine
Amodiaquine is a Mannich base 4 amino-quinoline that interferes with parasite haem detoxification. It is more effective than chloroquine in both chloroquine sensitive and resistant P. falciparum infections. However, there is cross-resistance between chloroquine and amodiaquine.
It is readily absorbed in the GIT and rapidly converted in the liver to the active metabolite, desethylamodiaquine. Desethylamodiaquine is responsible for all the antimalarial effect. Adverse effect of amodiaquine includes abdominal discomfort and vomiting weakness and when used for prophylaxis it causes agranulocytosis. Amodiaquine is recommended as a partner drug in artemisinin based combination therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Being resident in the project area
* Afebrile with no other malaria associated symptoms in the past 48 hours or at time of recruitment
* Consent to participate in the study obtained
* Can comply with 3 day DOT of standard SPAQ regimen (day 0-2)
* Willingness and ability of the childs guardians to comply with the study protocol for the duration of the study including all dry blood spot and slide collections
Exclusion Criteria
* Known allergy to medicine provided
* Receiving a sulfa-based medication for treatment or prophylaxis, including co-trimoxazole (trimethoprim-sulfamethoxazole).
* Individuals receiving azithromycin due to the antimalarial activity of azithromycin.
* Severe malnutrition according to WHO guidelines
* Recruited in cross sectional surveys or any other SMC studies.
3 Months
59 Months
ALL
Yes
Sponsors
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Malaria Consortium
OTHER
Responsible Party
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Principal Investigators
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Gauthier Tougri
Role: PRINCIPAL_INVESTIGATOR
NMCP Manager
Locations
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Unité de Recherche Clinique de Nanoro
Nanoro, , Burkina Faso
Countries
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Other Identifiers
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SMCBFPHASE1
Identifier Type: -
Identifier Source: org_study_id
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