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Clinical Trials/NCT06992297
NCT06992297CompletedNot Applicable

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

Assistance Publique Hopitaux De Marseille1 site in 1 country56 target enrollmentStarted: June 17, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
1
Primary Endpoint
frequency of long-term sequelae of severe malaria

Study Overview

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.

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

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

malaria patient

Other

Intervention: Questionnaire (Other)

Outcomes

Primary Outcomes

frequency of long-term sequelae of severe malaria

Time Frame: 12 months

Assessment of after-effects one year after diagnosis

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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