Combined Physical Rehabilitation and Individualized Nutritional Support Versus Standard of Care During In-hospital Endocarditis Treatment

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Infective endocarditis (IE) is associated with high morbidity and mortality. Patients with IE are affected by a lengthy hospitalization, leading to physical deconditioning and a rapid decline in physical fitness, muscle mass and strength. Moreover, prolonged antibiotic regimens frequently result in nausea, antibiotic-associated diarrhea and Clostridioides difficile (C.difficile) intestinal infections that further negatively affect patient health. These physical challenges are further exacerbated by the negative impact on mental health, increasing the overall burden of the illness. Implementing a targeted rehabilitative strategy in the hospital setting may therefore improve patient care including physical health and overall quality of life during hospitalization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinical diagnosis of left-sided (native, prosthetic, or culture-negative) bacterial infective endocarditis mandating iv antibiotic treatment, including Cardiac Implantable Electronic Devices infections, irrespective of cause and location as defined by the ESC modified Duke Criteria

• Age ≥ 18 years

Locations
Other Locations
Denmark
Hvidovre Hospital
RECRUITING
Hvidovre
Contact Information
Primary
Johannes Grand, MD PhD MPH
johannes.grand@regionh.dk
35452121
Backup
Jens Dahlgaard Hove, MD, PhD, MSc
jens.dahlgaard.hove@regionh.dk
Time Frame
Start Date: 2025-02-19
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 92
Treatments
Active_comparator: Integrated Physical Therapy and Nutritional Support with Probiotic Saccharomyces boulardii
Intensive physical therapy + individualised nutritional support + administration of probiotic yeast saccharomyces boulardii
Active_comparator: A combined Intensive physical Therapy and individualised Nutritional Support intervention
Intensive physical Therapy + Individualised Nutritional Support
Active_comparator: Administration of probiotic yeast Saccharomyces boulardii
Administration of probiotic yeast Saccharomyces boulardii
Placebo_comparator: Control group
Standard hospital care
Sponsors
Leads: Johannes Grand

This content was sourced from clinicaltrials.gov