NCT05979896

Chemoprevention Efficacy Study Nigeria

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Malaria Consortium · Academic / Other
• Sex: All
• Age: 3 Months – 59 Months
• Healthy volunteers: Accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-07-28
• Primary completion: 2023-09-15
• Completion: 2024-05-15
• First posted: 2023-08-07
• Last updated: 2023-08-07

Locations

1 site across 1 country: Nigeria