Clinical Practices for Treating Severe Malaria Caused by P. Falciparum

NCT07027722 | Completed

• 1 other identifier: 0066_SMIT
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at how doctors in three hospitals in France treat patients with a serious form of malaria caused by Plasmodium falciparum. It focuses on cases where the level of malaria parasites in the blood is 4% or higher. The study will compare how often a type of medicine called ACT (artemisinin-based combination therapy) is used on its own instead of the usual first-choice treatment (intravenous artesunate), and whether ACT works just as well. It will also check how well patients recover, whether they have complications, and how long they stay in the hospital.

Conditions

Malaria, Falciparum; Plasmodium Falciparum; Antimalarials; Artemisinins; Treatment Outcome; Drug Therapy, Combination; Retrospective Studies; Hospitalization

Outcome Measures

Primary Outcomes (1)

• Proportion of patients treated with artemisinin-based combination therapy (ACT) alone for Plasmodium falciparum malaria with parasitemia ≥4%.

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients (aged 18 years and older) who were hospitalized in one of the three participating centers over the past five years for Plasmodium falciparum malaria with a parasitemia level greater than or equal to 4%. These patients may or may not have presented with clinical signs of severity, and their treatment will have included either artemisinin-based combination therapy (ACT) or intravenous artesunate. Participants will be selected retrospectively from medical records based on these criteria.

You may qualify if:

• Adult patients aged 18 years or older.
• Diagnosis of Plasmodium falciparum malaria with a parasitemia level ≥ 4%.

You may not qualify if:

• \- Patients under 18 years old

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (1)

France

Saint-Denis, France, France

Location

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 18, 2025
• Study Start: May 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

FR (1)