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Chemoprevention Efficacy Study Nigeria - Trial NCT05979896

Access comprehensive clinical trial information for NCT05979896 through Pure Global AI's free database. This Phase 4 trial is sponsored by Malaria Consortium and is currently Recruiting. The study focuses on Malaria. Target enrollment is 800 participants.

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NCT05979896
Phase 4
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05979896
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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.

Study Focus

Malaria

Standard age based SPAQ administration for SMC

Interventional

drug

Sponsor & Location

Malaria Consortium

Kwara, Nigeria

Timeline & Enrollment

Phase 4

Jul 28, 2023

May 15, 2024

800 participants

Primary Outcome

Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites,Prevalence of antimalarial resistance markers among chemoprevention failures (as defined in outcome 1),Drug concentrations of Sulfadoxine-pyrimethamine and amodiaquine among chemoprevention failures (as defined in outcome 1),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

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.

ICD-10 Classifications

Unspecified malaria
Plasmodium malariae malaria
Plasmodium falciparum malaria
Other parasitologically confirmed malaria
Plasmodium ovale malaria

Data Source

ClinicalTrials.gov

NCT05979896

Non-Device Trial