Malaria, FalciparumNCT07027722
Clinical Practices for Treating Severe Malaria Caused by P. Falciparum
An observational study of Malaria, Falciparum and Plasmodium Falciparum, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malaria, Falciparum, Plasmodium Falciparum, Antimalarials
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adult patients aged 18 years or older.
- Diagnosis of Plasmodium falciparum malaria with a parasitemia level ≥ 4%.
Who cannot join
- Patients under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Malaria, Falciparum
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients treated with artemisinin-based combination therapy (ACT) alone for Plasmodium falciparum malaria with parasitemia ≥4%.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 May 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027722
- Sponsor's protocol ID
- 0066_SMIT
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Practices for Treating Severe Malaria Caused by P. Falciparum
- ClinicalTrials.gov ID
- NCT07027722
- Acronym / sponsor ID
- 0066_SMIT
- Conditions
- Malaria, Falciparum, Plasmodium Falciparum, Antimalarials, Artemisinins, Treatment Outcome, Drug Therapy, Combination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients aged 18 years or older.
- Diagnosis of Plasmodium falciparum malaria with a parasitemia level ≥ 4%.
Key exclusion criteria (1 listed)
- Patients under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients treated with artemisinin-based combination therapy (ACT) alone for Plasmodium falciparum malaria with parasitemia ≥4%.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, Falciparum and Plasmodium Falciparum, run by Centre Hospitalier de Saint-Denis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients treated with artemisinin-based combination therapy (ACT) alone for Plasmodium falciparum malaria with parasitemia ≥4%. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.