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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06992297
Acronym
SMAEE
Enrollment
56
Registered
2025-05-28
Start date
2025-06-17
Completion date
2025-09-13
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falciparum Malaria

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.

Interventions

OTHERQuestionnaire

a standardised, structured questionnaire, validated by the department's clinicians, to assess the physical, cognitive and psychological after-effects.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
frequency of long-term sequelae of severe malaria12 monthsAssessment of after-effects one year after diagnosis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026