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

NCT06992297 | Completed

• 2 other identifiers: AP-HM2025-A00117-48
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Falciparum Malaria

Outcome Measures

Primary Outcomes (1)

• frequency of long-term sequelae of severe malaria

  Assessment of after-effects one year after diagnosis

  12 months

Study Arms (1)

malaria patient

OTHER

Other: Questionnaire

Interventions

Questionnaire OTHER

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

malaria patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Francois CREMIEUX

  APHM

  STUDY DIRECTOR

• Coralie L'OLLIVIER, doctor

  APHM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: June 17, 2025
• Primary Completion: September 13, 2025
• Study Completion: September 13, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-09

Locations

FR (1)