Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera

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.

Study Overview

• Status: Completed
• Conditions: Mycobacterium Chimaera Infections
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Cardiac Surgery Clinic University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Oliver Reuthebuch, Prof. Dr. med., Cardiac Surgery Clinic University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: cardiac surgery; cardiac bypass heater-cooler devices
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Endocarditis
• Other Study ID Numbers: Req-2020-00373;ch20Reuthebuch2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No