Babesiosis, HumanBADIAGNCT04960995
Description of Case of Infection With a New Species of Babesia and Its Molecular Diagnosis
An observational study of Babesiosis, Human, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Babesiosis is a potentially very serious infection, but too little known. investigators want to raise their clinical colleagues and remind fellow biologists of the importance of choosing a good molecular diagnosis so as not to give false-negative results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Babesiosis, Human
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2021to 15 Jul 2021
- 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 subject suffering from severe babesiosis
Who may be able to join
- Major subject (≥18 years old)
- Splenectomized subject
- Subject with severe babesiosis
- Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research
Who cannot join
- Subject having expressed opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Parasitology and Medical Mycology Department - Strasbourg University Hospitals
Strasbourg, 67091
Alexander PFAFF, MCU-PH, 33 3 69 55 14 45, alexander.pfaff@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Babesiosis is a potentially very serious infection, but too little known. investigators want to raise their clinical colleagues and remind fellow biologists of the importance of choosing a good molecular diagnosis so as not to give false-negative results.
- Conditions
- Babesiosis, Human
- Keywords
- Babesiosis, BABESIA, ZOONOSES
- Medical subject headings
- Babesiosis, Zoonoses
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective study describing a case of infection with a new species of Babesia
Measured: The files analyzed retrospectively concern the period from January 01, 2020 to December 31, 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start10 Jul 2021
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Babesiosis, HumanStudies 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander PFAFF, MCU-PH, Principal investigator, Parasitology and Medical Mycology Department - Strasbourg University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960995
- Sponsor's protocol ID
- 8341
- Acronym
- BADIAG
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 23 Jul 2021
- 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Case of Infection With a New Species of Babesia and Its Molecular Diagnosis
- ClinicalTrials.gov ID
- NCT04960995
- Acronym / sponsor ID
- BADIAG / 8341
- Conditions
- Babesiosis, Human
- Keywords
- Babesiosis, BABESIA, ZOONOSES
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 14 Jul 2021 (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.
Babesiosis is a potentially very serious infection, but too little known. investigators want to raise their clinical colleagues and remind fellow biologists of the importance of choosing a good molecular diagnosis so as not to give false-negative results.
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 subject suffering from severe babesiosis
Key inclusion criteria (4 listed)
- Major subject (≥18 years old)
- Splenectomized subject
- Subject with severe babesiosis
- Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research
Key exclusion criteria (1 listed)
- Subject having expressed opposition to participating 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
A retrospective study describing a case of infection with a new species of Babesia
Time frame: The files analyzed retrospectively concern the period from January 01, 2020 to December 31, 2020.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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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.
Alexander PFAFF, MCU-PH principal investigator
Parasitology and Medical Mycology Department - Strasbourg University Hospitals
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 Babesiosis, Human, 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 4 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. 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 Alexander PFAFF, MCU-PH (33 3 69 55 14 45, alexander.pfaff@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A retrospective study describing a case of infection with a new species of Babesia (time frame: The files analyzed retrospectively concern the period from January 01, 2020 to December 31, 2020.). 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 23 Jul 2021.