Plasmodium VivaxDARCNCT05527119
Phenotyping and Genotyping of Duffy Antigen
An observational study of Plasmodium Vivax, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Malaria remains the world's leading parasitic endemic. Almost half of the world's population lives in endemic areas. Many at-risk people in African countries remain without access to malaria control. Malaria kills approximately 400,000 people each year, most of whom are children under the age of 5 in Africa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasmodium Vivax
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2022to 11 Sep 2023
- 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: - Major subjects with malaria and willing to have their blood samples analyzed for this research
Who may be able to join
- Major subjects
- with malaria and willing to have their blood samples analyzed for this research
Who cannot join
- Subjects refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Laboratoire de Parasitologie et Mycologie Médicale-PTM - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Malaria remains the world's leading parasitic endemic. Almost half of the world's population lives in endemic areas. Many at-risk people in African countries remain without access to malaria control. Malaria kills approximately 400,000 people each year, most of whom are children under the age of 5 in Africa. Since 2005, an increasing number of Plasmodium vivax infections have been observed in Duffy-negative populations in South America and Africa, calling into question the essential role of the PvDBP-DARC interaction. The objective of the investigators is therefore to study and understand the invasion pathways used by Plasmodium vivax in Duffy-negative subjects.
- Conditions
- Plasmodium Vivax
- Keywords
- Malaria, Malaria, Vivax, PvDBP-DARC interaction, Plasmodium vivax, Duffy-negative, Duffy Binding Protein, PvDBP, Duffy Antigen Receptor for Chemokines
- Medical subject headings
- Malaria, Vivax, Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood samples tested (phenotype and genotype).
Measured: 2 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start11 Mar 2022
- Primary completion11 Jul 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium VivaxStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier MENARD, MD, PhD, Principal investigator, Service Laboratoire de Parasitologie et Mycologie Médicale-PTM - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527119
- Sponsor's protocol ID
- 8543
- Acronym
- DARC
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping and Genotyping of Duffy Antigen
- ClinicalTrials.gov ID
- NCT05527119
- Acronym / sponsor ID
- DARC / 8543
- Conditions
- Plasmodium Vivax
- Keywords
- Malaria, Malaria, Vivax, PvDBP-DARC interaction, Plasmodium vivax, Duffy-negative, Duffy Binding Protein, PvDBP, Duffy Antigen Receptor for Chemokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 2 Sep 2022 (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.
Malaria remains the world's leading parasitic endemic. Almost half of the world's population lives in endemic areas. Many at-risk people in African countries remain without access to malaria control. Malaria kills approximately 400,000 people each year, most of whom are children under the age of 5 in Africa. Since 2005, an increasing number of Plasmodium vivax infections have been observed in Duffy-negative populations in South America and Africa, calling into question the essential role of the PvDBP-DARC interaction. The objective of the investigators is therefore to study and understand the invasion pathways used by Plasmodium vivax in Duffy-negative subjects.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - Major subjects with malaria and willing to have their blood samples analyzed for this research
Key inclusion criteria (2 listed)
- Major subjects
- with malaria and willing to have their blood samples analyzed for this research
Key exclusion criteria (1 listed)
- Subjects refusing to participate in the study
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
Number of blood samples tested (phenotype and genotype).
Time frame: 2 months later
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 8 Nov 2023.
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RecruitingPhase 1
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
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Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years
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This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria
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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.
Didier MENARD, MD, PhD principal investigator
Service Laboratoire de Parasitologie et Mycologie Médicale-PTM - CHU de Strasbourg - France
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 Plasmodium Vivax, run by University Hospital, Strasbourg, France 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 8 Nov 2023. 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?
Number of blood samples tested (phenotype and genotype). (time frame: 2 months later). 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 8 Nov 2023.