Accelerated Treatment of Endocarditis

Not Applicable

• Conditions: Infectious Endocarditis
• Interventions: Other: Accelerated treatment of endocarditis; Other: Usual guideline therapy

• Registration Number: NCT03851575
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks with one or two types of intravenously administered antibiotics. The long hospitalization increases several risks for the patient, including mental strain and increased loss of function. Furthermore, it poses a significant burden on health systems. Current guidelines fail to use available data collected from patients (echo, temperature, CRP, leukocytes, procalcitonin etc.) to determine duration of treatment. A strategy including these data in treatment algorithms ensures an individualized treatment, targeting the patient's course and response to treatment. Thus, the purpose of this open-label, prospective, non-inferiority, RCT study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 750 patients, approx. 200 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus). Interim analysis will be conducted when 150 patients have been included, to assess the frequency of the event rate and inclusion rate in order to adjust the intended size of the study population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-03
• Study Start: 2019-01-17
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06
• Primary Completion: 2023-06-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1. Patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised Duke criteria.
2. The patient may be included <14 days after beginning of relevant antibiotic treatment.
3. Left-sided endocarditis with one of the following microorganisms: Streptococci; Enterococcus faecalis; Staphylococcus aureus.
4. Patients ≥ 18 years.

Exclusion Criteria

1. Known / suspected immunocompetence (HIV, chemotherapy, prednisolone treatment (> 20 mg / day)).
2. Incapability to give informed consent for participation.
3. Relapse Endocarditis (Endocarditis with the same bacteria within six months).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated arm	Accelerated treatment of endocarditis	Accelerated treatment of endocarditis
Control arm	Usual guideline therapy	Usual guideline therapy

Primary Outcome Measures

Name	Time	Method
Primary composite endpoint	6 monts after randomization	Number of patients with at least one of the following: Death (yes/no); Embolisms (yes/no); Bacteraemia with the same microorganism (yes/no), surgery not planned at randomization (yes/no).

Secondary Outcome Measures

Name	Time	Method
Expenses	6 monts after randomization	Expenses associated with hospitalization and treatment of the disease. I.E., expenses to admission, examinations and medicine
Bacteraemia with the same microorganism,	6 monts after randomization	Number of patients that have Bacteraemia with the same microorganism
Surgery not planned at randomization	6 monts after randomization	Number of patients that have Surgery not planned at randomization
Quality of life	6 monts after randomization and after	Quality of life assessed by completing short version 36 (SF 36) version 2
Duration of hospitalization	6 monts after randomization	Duration of hospitalization
Death	6 monts after randomization	Number of patients that die
Embolisms	6 monts after randomization	Number of patients that have an embolism

Trial Locations

Locations (7)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Gentofte Hospital; 🇩🇰 Copenhagen, Denmark

Skejby Sygehus; 🇩🇰 Aarhus, Denmark

Hillerød Hospital; 🇩🇰 Hillerød, Denmark

Herlev Hoslpital; 🇩🇰 Copenhagen, Denmark

Odense Sygehus; 🇩🇰 Odense, Denmark

Roskilde Sygehus; 🇩🇰 Roskilde, Denmark