Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423898
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-13
Brief Title:
Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Overview
Official Title:
Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Intermittent Infusion for the Treatment of Enterococcus Faecalis Infective Endocarditis DOBLEI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOBLEI
Brief Summary:
Phase IV open-label randomized and multicenter clinical trial to prove that patients with Enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard intermittent infusion regimen usually administered in hospitalized patients
Detailed Description:
The aim of the study is to prove that the continuous infusion of antibiotic treatment for the patients with Enterococcus faecalis infective endocarditis is as effective and safe as the traditional intermittent infusion The continuous infusion modality of treatment is expected to provide numerous benefits for individual patients global health and for the National Health Care System by reducing to hospital stays from 4-6 weeks to approximately 2-3 weeks and hospital-driven complications
The mortality rate of serious adverse events total number of days of antibiotic treatment and days of hospitalization among others are included as secondary objectives
This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients Final contact and final visit for the study will be performed at 365 days after the 42 days of treatment
The mortality rate of serious adverse events total number of days of antibiotic treatment and days of hospitalization among others are included as secondary objectives
This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients Final contact and final visit for the study will be performed at 365 days after the 42 days of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None