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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-17

Study Completion Date

2025-09-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Rapid Diagnosis Tests in Imported Malaria

NCT00451269

Malaria

COMPLETED

PALUREA: Severe Imported Malaria in Adults

NCT00372684

Malaria

COMPLETED

Malaria Transmission Studies in Mali

NCT01829737

Malaria, Falciparum

COMPLETED

Impact of Malaria on Pregnant Women in Ouelessebougou, Mali

NCT02974608

Malaria

COMPLETED

Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.

NCT04494854

Malaria Disease, Infectious Travel-Associated Infections

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Falciparum Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

malaria patient

Group Type OTHER

Questionnaire

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No