NCT04429256

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

June 9, 2020

Last Update Submit

November 20, 2023

Conditions

Mycobacterium Chimaera Infections

Keywords

cardiac bypass heater-cooler devicescardiac surgery

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

data collectionOTHER

retrospective analysis of perioperative data collected from patient medical charts and from a telephone enquiry

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Surgery Clinic University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Oliver Reuthebuch, Prof. Dr. med.

    Cardiac Surgery Clinic University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 12, 2020

Study Start

April 10, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

CH(1)