Mycobacterium Chimaera InfectionsNCT04429256
Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera
An observational study of Mycobacterium Chimaera Infections, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices. So far optimal therapeutical concepts are not clear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycobacterium Chimaera Infections
- What is being tested?
- data collection
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Apr 2020to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel
Who may be able to join
- Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cardiac Surgery Clinic University Hospital Basel
Basel, 4031
About this study
Official title: Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera: Diagnosis, Course of Disease, and Therapy Recommendations
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices.
So far optimal therapeutical concepts are not clear. At the University Hospital Basel Mycobacterium chimaera- infected protheses are replaced to decrease pathogenic burden and to support antibiotic long- term treatment. This study is to analyze the efficacy of this therapeutic approach.
- Conditions
- Mycobacterium Chimaera Infections
- Being tested
- data collection
- Keywords
- cardiac bypass heater-cooler devices, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
retrospective analysis of perioperative data collected from patient medical charts and from a telephone enquiry
What is being measured
The primary outcome is the main question the study is designed to answer.
summary of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery
Descriptive statistical analysis of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery
Measured: at baseline
summary of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery
Descriptive statistical analysis of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start10 Apr 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Chimaera InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Reuthebuch, Prof. Dr. med., Principal investigator, Cardiac Surgery Clinic University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429256
- Sponsor's protocol ID
- Req-2020-00373;ch20Reuthebuch2
- Status last verified
- Nov 2023
- First submitted
- 9 Jun 2020
- Last updated
- 21 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera: Diagnosis, Course of Disease, and Therapy Recommendations
- ClinicalTrials.gov ID
- NCT04429256
- Acronym / sponsor ID
- Req-2020-00373;ch20Reuthebuch2
- Conditions
- Mycobacterium Chimaera Infections
- Keywords
- cardiac bypass heater-cooler devices, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Jun 2020 (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.
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices.
So far optimal therapeutical concepts are not clear. At the University Hospital Basel Mycobacterium chimaera- infected protheses are replaced to decrease pathogenic burden and to support antibiotic long- term treatment. This study is to analyze the efficacy of this therapeutic approach.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel
Key inclusion criteria (1 listed)
- Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionretrospective analysis of perioperative data collected from patient medical charts and from a telephone enquiry | Other | – |
Primary outcome
summary of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery
Time frame: at baseline
Descriptive statistical analysis of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery
summary of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery
Time frame: at baseline
Descriptive statistical analysis of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery
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 21 Nov 2023.
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.
Oliver Reuthebuch, Prof. Dr. med. principal investigator
Cardiac Surgery Clinic University Hospital Basel
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 Mycobacterium Chimaera Infections, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 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 21 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 Switzerland. 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?
summary of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery (time frame: at baseline). The study lists 2 primary outcomes in all. 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 21 Nov 2023.