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Clinical trial

Seasonal Malaria Chemoprevention in Burkina Faso : Chemoprevention Efficacy Study

ID
Name
SMCBFPHASE1
Description
The aim of this study is to determine whether Seasonal Malaria Chemoprevention (SMC) remains effective in the health district of Nanoro in the Centre-Ouest region or Boussé in the Plateau Central region. It also aims to assess the protective efficacy of the antimalarial drugs used in SMC in the target population and to investigate levels of parasite resistance in the study districts. According to the results, this trial should provide the evidence needed to change the drugs used in SMC. 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.
Trial arms
Trial start
2022-07-15
Estimated PCD
2022-10-01
Trial end
2023-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)
Other names:
SP
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.
Arms:
Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)
Other names:
AQ
Size
800
Primary endpoint
Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites
One month
Prevalence of antimalarial resistance markers among chemoprevention failures (as defined in outcome 1)
One month
Drug concentrations of Sulfadoxine-pyrimethamine and amodiaquine among chemoprevention failures (as defined in outcome 1)
One month
Eligibility criteria
Inclusion Criteria: * Children between 3-59 months * 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: * Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours) * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cohort', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 800, 'type': 'ACTUAL'}}
Updated at
2023-11-01

1 organization

2 products

1 indication

Organization
Malaria Consortium
Product
Sulfadoxine pyrimethamine
Indication
Malaria
Product
Amodiaquine