ClinicalTrials.Veeva

Menu

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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Falciparum Malaria

Treatments

Other: Questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT06992297
AP-HM (Registry Identifier)
2025-A00117-48 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

56 participants in 1 patient group

malaria patient
Other group
Treatment:
Other: Questionnaire

Trial contacts and locations

1

Loading...

Central trial contact

alexandra GIULIANI, PROJECT MANAGER

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems