Acinetobacter BaumanniiBaumanniiNCT06173440
Management of an Imipenem-resistant Acinetobacter Baumannii Alert in a French University Hospital
An observational study of Acinetobacter Baumannii, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Colonization with imipenem-resistant Acinetobacter baumannii (IBA) is an unfavorable event for the patient, especially in intensive care. Indeed, it exposes the patient to the risk of developing serious infections, extremely difficult to treat. ABRI is a particularly resistant bacterium in the environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acinetobacter Baumannii
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: Major subject (≥18 years old) having been hospitalized in the surgical resuscitation service of Hautepierre during the ABRI epidemic, between 01/05/2015 and 01/01/2019 inclusive and having been colonized and/or infected by ABRI
Who may be able to join
- Major subject (≥18 years old)
- Patient having been hospitalized in the surgical resuscitation service of Hautepierre during the ABRI epidemic, between 01/05/2015 and 01/01/2019 inclusive and having been colonized and/or infected by ABRI (according to bacteriological results transmitted to the hygiene service).
- Subject having given his/her agreement, after information, for the reuse of his/her data for the purpose of this research
Who cannot join
- Subject having expressed his opposition to participate in the study
- Subject under guardianship or curatorship
- Subject under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Equipe opérationnelle d'hygiène - CHU de Strasbourg - France
Strasbourg, 67091
Stéphanie DEBOSCKER, MD, 33 3 69 55 03 10, stephanie.deboscker@chru-strasbourg.fr
Stéphanie DEBOSCKER, MD
About this study
Official title: Management of an Imipenem-resistant Acinetobacter Baumannii Alert in a French University Hospital: A Retrospective Study
Colonization with imipenem-resistant Acinetobacter baumannii (IBA) is an unfavorable event for the patient, especially in intensive care. Indeed, it exposes the patient to the risk of developing serious infections, extremely difficult to treat. ABRI is a particularly resistant bacterium in the environment. When an ABRI epidemic occurs in a department as central to the hospital as a surgical resuscitation department, the control of such an event can be extremely complex. There are few clear and detailed descriptions in the literature of how to manage this type of outbreak, let alone an ABRI outbreak of this magnitude.
- Conditions
- Acinetobacter Baumannii
- Keywords
- Acinetobacter baumannii, Imipenem-resistant
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the management of an imipenem-resistant Acinetobacter baumannii outbreak that occurred from 2015 to 2019 in a surgical intensive care unit
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jan 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinetobacter BaumanniiStudies 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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173440
- Sponsor's protocol ID
- 7588
- Acronym
- Baumannii
- Status last verified
- Dec 2023
- First submitted
- 7 Nov 2022
- Last updated
- 15 Dec 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of an Imipenem-resistant Acinetobacter Baumannii Alert in a French University Hospital: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06173440
- Acronym / sponsor ID
- Baumannii / 7588
- Conditions
- Acinetobacter Baumannii
- Keywords
- Acinetobacter baumannii, Imipenem-resistant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Dec 2023 (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.
Colonization with imipenem-resistant Acinetobacter baumannii (IBA) is an unfavorable event for the patient, especially in intensive care. Indeed, it exposes the patient to the risk of developing serious infections, extremely difficult to treat. ABRI is a particularly resistant bacterium in the environment. When an ABRI epidemic occurs in a department as central to the hospital as a surgical resuscitation department, the control of such an event can be extremely complex. There are few clear and detailed descriptions in the literature of how to manage this type of outbreak, let alone an ABRI outbreak of this magnitude.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) having been hospitalized in the surgical resuscitation service of Hautepierre during the ABRI epidemic, between 01/05/2015 and 01/01/2019 inclusive and having been colonized and/or infected by ABRI
Key inclusion criteria (3 listed)
- Major subject (≥18 years old)
- Patient having been hospitalized in the surgical resuscitation service of Hautepierre during the ABRI epidemic, between 01/05/2015 and 01/01/2019 inclusive and having been colonized and/or infected by ABRI (according to bacteriological results transmitted to the hygiene service).
- Subject having given his/her agreement, after information, for the reuse of his/her data for the purpose of this research
Key exclusion criteria (3 listed)
- Subject having expressed his opposition to participate in the study
- Subject under guardianship or curatorship
- Subject under legal protection
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
Retrospective description of the management of an imipenem-resistant Acinetobacter baumannii outbreak that occurred from 2015 to 2019 in a surgical intensive care unit
Time frame: Through study completion, an average of 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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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.
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 Acinetobacter Baumannii, 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 3 inclusion and 3 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 15 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie DEBOSCKER, MD (33 3 69 55 03 10, stephanie.deboscker@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the management of an imipenem-resistant Acinetobacter baumannii outbreak that occurred from 2015 to 2019 in a surgical intensive care unit (time frame: Through study completion, an average of 5 months). 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 15 Dec 2023.