Clinical Evaluation of Long-term Sequelae in Patients With Severe Plasmodium Falciparum Malaria

Not Applicable

Not yet recruiting

• Conditions: Falciparum Malaria

• Registration Number: NCT06992297
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Malaria, endemic in 85 countries, remains a major concern. By 2022, there will be 249 million cases and 608,000 deaths, 94% of them in Africa. In France, 4995 cases of imported malaria were reported in 2021, with 15% of severe forms and a fatality rate of 2.5%. Long-term sequelae, such as kidney failure and neurological disorders, are well documented in children, but few studies have focused on adults.

Our main objective is to describe and estimate the frequency of long-term sequelae of severe imported malaria treated at our centre.

Our aim is to compare long-term neurological sequelae between neuromalaria and severe malaria without neurological disorders. In addition, we aim to identify the clinical, radiological and biological factors associated with sequelae in order to improve post-hospitalisation follow-up. Finally, we aim to describe acute complications arising at diagnosis and during hospitalisation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study Start: 2025-05-20
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-05-20
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Male or female over 18 years of age
• Have been diagnosed with severe malaria according to WHO criteria and have been treated between 1/1/2018 and 321/12/2024 at the AP-HM
• Have been treated with Artesunate IV (MALACEF®) (at least one dose)
• Patient who has received information about the study and has not expressed opposition
• Patient benefiting or entitled to benefit from a social security scheme

Exclusion Criteria

• Patients with advanced neurodegenerative pathology pre-existing the malaria attack
• Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code (minor patients, patients of legal age under guardianship, curatorship or safeguard of justice, patients deprived of their liberty, pregnant or breast-feeding women),
• Persons who do not understand French

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
frequency of long-term sequelae of severe malaria	12 months	Assessment of after-effects one year after diagnosis

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France