Accelerated Treatment of Endocarditis

Infectious Endocarditis Clinical Trial

— POETII  

Official title:

Accelerated Treatment of Endocarditis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03851575
• Other study ID #: H-18028566
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: December 10, 2023

Study information

• Verified date: February 2020
• Source: Rigshospitalet, Denmark
• Contact: Kasper K Iversen, MD
• Phone: +4528712753
• Email: kasper.k.iversen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Endocarditis
• Infectious Endocarditis

Intervention

Other:
• Accelerated treatment of endocarditis
For the three main bacteria species we shorten the duration of antibiotic treatment
• Usual guideline therapy
Usual guideline therapy

Locations

Country	Name	City	State
Denmark	Skejby Sygehus	Aarhus
Denmark	Gentofte Hospital	Copenhagen
Denmark	Herlev Hoslpital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Hillerød Hospital	Hillerød
Denmark	Odense Sygehus	Odense
Denmark	Roskilde Sygehus	Roskilde

Sponsors (7)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aarhus University Hospital, Herlev Hospital, Lund University Hospital, Nordsjaellands Hospital, Odense University Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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