Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera

Mycobacterium Chimaera Infections Clinical Trial

Official title:

Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera: Diagnosis, Course of Disease, and Therapy Recommendations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429256
• Other study ID #: Req-2020-00373;ch20Reuthebuch2
• Status: Completed
• Start date: April 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Endocarditis
• Mycobacterium Chimaera Infections
• Mycobacterium Infections

Intervention

Other:
• data collection
retrospective analysis of perioperative data collected from patient medical charts and from a telephone enquiry

Locations

Country	Name	City	State
Switzerland	Cardiac Surgery Clinic University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at baseline
Primary	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	at baseline