MalariaACMUSNCT03594084
Malaria in Strasbourg University Hospital
An observational study of Malaria, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Malaria
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2018to Aug 2019
- 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 1 day and older
- All sexes
- Child, Adult, Older adult
Study population: iagnosis patients with malaria from 01/01/2017 to 01/01/2018
Who may be able to join
- Patients from birth to 18 years
- Patient submitted to guardianship
- Patient submitted to trusteeship
- Diagnosis patients with malaria from 01/01/2017 to 01/01/2018
- Patient or legal representative agree to use medical data for this research
Who cannot join
- Lack of confirmation malaria diagnosis
- Impossibility to inform patients
- Patient who does not wish to participate in the study
- Patient submitted to justice safeguarding
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Maladies Infectieuses et Tropicales
Strasbourg, 67091
Xavier ARGEMI, MD, 33 3 69 55 11 87, xavier.argemi@chru-strasbourg.fr
Anne DINDOYAL, MD, 33 3 69 55 11 87, anne.dindoyal@chru-strasbourg.fr
About this study
Official title: Retrospective Clinical Study of Malaria in Strasbourg University
The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. In addition, The investigators observed a variation in the laboratory diagnostic performance of malaria between hospital and private laboratories. Such observation also needed to be analyzed objectively
- Conditions
- Malaria
- Keywords
- Malaria, Malaria imported cases, Recurrent malaria, Endemic malaria areas, Biological diagnosis, Hospital vs private laboratory diagnosis
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of clinical characteristics of imported malaria in people originated from endemic areas hospitalized at Strasbourg University Hospital from 2017 to 2018.
Measured: The period from January 1st, 2017 to January 1st, 2018 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Aug 2018
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier ARGEMI, MD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594084
- Sponsor's protocol ID
- 7084
- Acronym
- ACMUS
- Status last verified
- Jul 2018
- First submitted
- 10 Jul 2018
- Last updated
- 17 Sep 2018
- 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 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Study of Malaria in Strasbourg University
- ClinicalTrials.gov ID
- NCT03594084
- Acronym / sponsor ID
- ACMUS / 7084
- Conditions
- Malaria
- Keywords
- Malaria, Malaria imported cases, Recurrent malaria, Endemic malaria areas, Biological diagnosis, Hospital vs private laboratory diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 Jul 2018 (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.
The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. In addition, The investigators observed a variation in the laboratory diagnostic performance of malaria between hospital and private laboratories. Such observation also needed to be analyzed objectively
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- iagnosis patients with malaria from 01/01/2017 to 01/01/2018
Key inclusion criteria (5 listed)
- Patients from birth to 18 years
- Patient submitted to guardianship
- Patient submitted to trusteeship
- Diagnosis patients with malaria from 01/01/2017 to 01/01/2018
- Patient or legal representative agree to use medical data for this research
Key exclusion criteria (4 listed)
- Lack of confirmation malaria diagnosis
- Impossibility to inform patients
- Patient who does not wish to participate in the study
- Patient submitted to justice safeguarding
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
Study of clinical characteristics of imported malaria in people originated from endemic areas hospitalized at Strasbourg University Hospital from 2017 to 2018.
Time frame: The period from January 1st, 2017 to January 1st, 2018 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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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.
Xavier ARGEMI, MD study director
University Hospital, 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 Malaria, 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier ARGEMI, MD (33 3 69 55 11 87, xavier.argemi@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of clinical characteristics of imported malaria in people originated from endemic areas hospitalized at Strasbourg University Hospital from 2017 to 2018. (time frame: The period from January 1st, 2017 to January 1st, 2018 will be examined). 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 17 Sep 2018.