Clinical trial
A Study Protocol to Assess the Chemoprevention Efficacy of Sulphadoxine-Pyrimethamine Plus Amodiaquine (SPAQ) and Resistance Marker Prevalence in Children 3-59 Months in Sokoto and Kwara States, Nigeria.
Name
SMCNGPHASE1
Description
The study aims to assess the chemoprevention efficacy of Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) used in standard age-based dosing regimens used in Seasonal Malaria Chemoprevention (SMC) and SPAQ resistance marker prevalences and assocations among children 3 - 59 months in Sokoto and Kwara States, Nigeria.
Trial arms
Trial start
2023-07-28
Estimated PCD
2023-09-15
Trial end
2024-05-15
Status
Recruiting
Phase
Early phase I
Treatment
Standard age based SPAQ administration for SMC
Sulfadoxine-pyrimethamine and amodiaquine (SPAQ) is administered in standard WHO approved age based regimens as used in Seasonal Malaria Chemoprevention Programmes.
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.
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. AQ 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.
Arms:
Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)
Size
800
Primary endpoint
Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites
28 days
Prevalence of antimalarial resistance markers among chemoprevention failures (as defined in outcome 1)
28 days
Drug concentrations of Sulfadoxine-pyrimethamine and amodiaquine among chemoprevention failures (as defined in outcome 1)
28 days
Prevalence over time of parasites with dhfr/dhps/pfcrt/pfmdr1 mutations in symptomatic children with a positive diagnostic test residing in districts where SMC is implemented
28 days preceding implementation of chemoprevention efficacy study component
Eligibility criteria
Inclusion criteria
* Children between 3-59 months.
* Being resident in the research study area.
* Afebrile children 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 days DOT of standard SPAQ regimen.
* Willingness and ability of the child's 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 SPAQ.
* 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
* HIV positive or ARV use (SPAQ MUST NEVER be used with children taking the antiretroviral efavirenz)
* Chronic illness of any kind.
* Treatment with an ACT in previous 2 weeks.
* Previous treatment with SPAQ this malaria season.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cohort', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 800, 'type': 'ESTIMATED'}}
Updated at
2023-08-07
1 organization
1 product
1 indication
Organization
Malaria ConsortiumIndication
Malaria