NCT06107309

Brief Summary

Endocarditis are deadly infections, which nowadays occurs mainly among older patients with multiple comorbidities. The incidence is notably high among patients with valvular prosthetic or implantable devices. Management of such situation usually requires intravenous antibiotic therapy along with removal of the infected prosthetic or device. However, such invasive procedures and revision surgeries may be judged unreasonable among these patients, who are then exposed to a high risk of infectious relapse when curative antibiotics are discontinued. In these situation, a long-course antibiotic therapy may be used in order to maintain lasting infection control, to limit the risks of relapse of infection due to the infected device retention, and ultimately to prolong survival. This strategy is already suggested in case of infected prosthesis joint retention (IDSA 2013), and has been proposed for implantable device retention by the American Heart Rhythm Society in 2017, but data regarding its modalities and outcomes are scare. The objectives of this study are to describe the survival of patient under long-term antibiotic therapy for endocarditis, at 6-months and 1 year after initiation. Secondary outcomes includes modalities of the suppressive treatment prescribed, its security (secondary effects, tolerance) and to precise causes of death.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 24, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

EndocarditisAntibiotic therapySuppressive antibioticsLong term treatment

Outcome Measures

Primary Outcomes (1)

  • Survival of the patient who benefited from suppressive antibiotic therapy

    Survival at 6 months, 1 year, 3 years after infection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major subject (≥18 years old) having benefited from suppressive antibiotic therapy after collegial decision in CPR Endocarditis during the period from January 1, 2016 to January 31, 2023

You may qualify if:

  • Major subject (≥18 years old)
  • Subject having benefited from suppressive antibiotic therapy after collegial decision in CPR Endocarditis during the period from January 1, 2016 to January 31, 2023
  • Subject not opposing the reuse of their data for the purposes of this research.

You may not qualify if:

  • Subject having expressed opposition to participating in the study
  • Death or loss of sight of the patient before initiation of suppressive antibiotic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations