Clinical Trial: Elucidating the Association Between First-Line Antimalarial Drug Susceptibility and Patient Outcomes in African Severe Malaria: A Prospective Cohort Study Towards Improving Survival Rates (Japan)

Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061551) titled 'Elucidating the Association Between First-Line Antimalarial Drug Susceptibility and Patient Outcomes in African Severe Malaria: A Prospective Cohort Study Towards Improving Survival Rates' on May 15.

Study Type: Observational

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Malaria Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - Although malaria-related deaths initially declined following the introduction of the highly effective antimalarial drug artemisinin, the trend reversed in 2020 and has since plateaued, resulting in approximately 600,000 deaths annually. The African region, in particular, accounts for 95% of these fatalities. Why, then, do malaria deaths remain so high? In 2021, the regional spread of kelch13 mutations associated with decreased artemisinin susceptibility and delayed clinical parasite clearance was demonstrated for the first time in Africa, specifically in Northern Uganda (Balikagara et al., 2021). While the association with clinical outcomes remains unclear at present, the applicant hypothesizes that the blunted rapid efficacy of treatment due to kelch13 mutations contributes to the persistently high mortality.

In this study, we will conduct the first prospective cohort study targeting severe cases in Northern Uganda. By comprehensively exploring prognostic factors from multiple perspectives, including parasite genotypes, in vivo and in vitro drug susceptibility, and patient background, we aim to optimize treatment strategies and improve survival rates. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 6 months-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 6 months or older, weighing 5 kg or more, who meet the 2025 WHO diagnostic criteria for severe malaria. Key exclusion criteria - Patients who have received antimalarial treatment within 2 weeks prior to enrollment. Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 11 Day Anticipated trial start date - 2026 Year 05 Month 31 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070366

Disclaimer: Curated by HT Syndication.