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NCT06107309 Clinical Trial

Suppressive Antibiotic Therapy for Endocarditis

Endocarditis Clinical Trial

— SATIE  

Official title:
Suppressive Antibiotic Therapy for Prosthetic Valve or Implantable Device Related Infectious Endocarditis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06107309
Other study ID # 8900
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date March 2024

Study information
Verified date October 2023
Source University Hospital, Strasbourg, France
Contact Yvon RUCH, MD
Phone 33 3 69 55 12 19
Email yvon.ruch@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - 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. Exclusion criteria: - Subject having expressed opposition to participating in the study - Death or loss of sight of the patient before initiation of suppressive antibiotic therapy.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival of the patient who benefited from suppressive antibiotic therapy Survival at 6 months, 1 year, 3 years after infection
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