Evaluating infection management in children with heart-assist devices
Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.
Claude Bernard University · NCT06464016
This study looks at how to better manage infections in children using heart-assist devices to help improve their health while they wait for a heart transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 47 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Claude Bernard University (other) |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06464016 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children under 18 years of age who are receiving mechanical circulatory support using the Berlin Heart EXCOR device. It aims to evaluate the management of infections, which are common complications in patients with heart-assist devices. The study will gather data on infection rates and treatment approaches to improve outcomes for pediatric patients awaiting heart transplantation. The findings could help refine current guidelines and recommendations for infection management in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 18 years old who are currently receiving support from the Berlin Heart EXCOR device.
Not a fit: Patients over 18 years old or those without proper documentation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved infection management strategies for children with heart-assist devices, potentially reducing morbidity and mortality.
How similar studies have performed: There is limited existing research on infection management in pediatric patients with mechanical support, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients under 18yo of age with Berlin Heart assisting device in Hospices Civils de Lyon, in France. Exclusion Criteria: * patients over 18 yo at the time of BH assistance * unavailable documentation
Where this trial is running
Lyon
- Hospices Civils de Lyon — Lyon, France (RECRUITING)
Study contacts
- Study coordinator: Charlotte Leclercq, MD PhD
- Email: chaleclercq@gmail.com
- Phone: +33787022785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart-Assist Devices, Infections, Heart Transplant Infection