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OpenTrials
Completed

NCT Number: NCT06992297

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

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.

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Key information

Conditions

Falciparum Malaria Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. frequency of long-term sequelae of severe malaria

    Time frame: 12 months

    Assessment of after-effects one year after diagnosis

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: SMAEE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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