Clinical trial NCT05979896: Chemoprevention Efficacy Study Nigeria
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Malaria
Keywords: Seasonal Malaria Chemoprevention
Chemoprevention efficacy
Antimalarial drug resistance
Lead sponsor: Malaria Consortium
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 800
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The study aims (1) to determine the chemoprevention efficacy of Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) used in standard age-based dosing regimens for Seasonal Malaria Chemoprevention (SMC) in children 3-59 months and (2) determine the prevalences and associations of drug resistance genotypes associated with resistance to SPAQ.

1. a prospective cohort study to determine the chemoprevention efficacy of SPAQ (if SPAQ provides 28 days of protection from Plasmodium falciparum (P. falciparum) malaria infection by clearing existing and preventing new infections) and whether drug concentrations and/or resistance influence the ability to clear and prevent these P. falciparum infections.
2. a resistance markers study in symptomatic RDT positive children 3-59 months to measure sulfadoxine-pyrimethamine and amodiaquine resistance marker prevalence and association.

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.

Primary outcomes:
measure: Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites
timeFrame: 28 days
measure: Prevalence of antimalarial resistance markers among chemoprevention failures (as defined in outcome 1)
timeFrame: 28 days
measure: Drug concentrations of Sulfadoxine-pyrimethamine and amodiaquine among chemoprevention failures (as defined in outcome 1)
timeFrame: 28 days
measure: 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
timeFrame: 28 days preceding implementation of chemoprevention efficacy study component
Secondary outcomes:
Other outcomes:
Locations:
city: Kwara
country: Nigeria
facility: Kwara Sentinell Site
Study officials:
affiliation: Malaria Consortium
name: Craig Bonnington
role: PRINCIPAL_INVESTIGATOR
References: