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Accelerated Treatment of Endocarditis (POETII)

Primary Purpose

Infectious Endocarditis

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Accelerated treatment of endocarditis
Usual guideline therapy
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infectious Endocarditis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Skejby SygehusRecruiting
  • RigshospitaletRecruiting
  • Gentofte HospitalRecruiting
  • Herlev HoslpitalRecruiting
  • Hillerød HospitalRecruiting
  • Odense SygehusRecruiting
  • Roskilde SygehusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm

Accelerated arm

Arm Description

Usual guideline therapy

Accelerated treatment of endocarditis

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2018
Last Updated
February 4, 2020
Sponsor
Rigshospitalet, Denmark
Collaborators
Herlev Hospital, Nordsjaellands Hospital, Zealand University Hospital, Odense University Hospital, Aarhus University Hospital, Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03851575
Brief Title
Accelerated Treatment of Endocarditis
Acronym
POETII
Official Title
Accelerated Treatment of Endocarditis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Herlev Hospital, Nordsjaellands Hospital, Zealand University Hospital, Odense University Hospital, Aarhus University Hospital, Lund University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Endocarditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Usual guideline therapy
Arm Title
Accelerated arm
Arm Type
Experimental
Arm Description
Accelerated treatment of endocarditis
Intervention Type
Other
Intervention Name(s)
Accelerated treatment of endocarditis
Intervention Description
For the three main bacteria species we shorten the duration of antibiotic treatment
Intervention Type
Other
Intervention Name(s)
Usual guideline therapy
Intervention Description
Usual guideline therapy
Primary Outcome Measure Information:
Title
Primary composite endpoint
Description
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).
Time Frame
6 monts after randomization
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life assessed by completing short version 36 (SF 36) version 2
Time Frame
6 monts after randomization and after
Title
Expenses
Description
Expenses associated with hospitalization and treatment of the disease. I.E., expenses to admission, examinations and medicine
Time Frame
6 monts after randomization
Title
Duration of hospitalization
Description
Duration of hospitalization
Time Frame
6 monts after randomization
Title
Death
Description
Number of patients that die
Time Frame
6 monts after randomization
Title
Embolisms
Description
Number of patients that have an embolism
Time Frame
6 monts after randomization
Title
Bacteraemia with the same microorganism,
Description
Number of patients that have Bacteraemia with the same microorganism
Time Frame
6 monts after randomization
Title
Surgery not planned at randomization
Description
Number of patients that have Surgery not planned at randomization
Time Frame
6 monts after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised Duke criteria. The patient may be included <14 days after beginning of relevant antibiotic treatment. Left-sided endocarditis with one of the following microorganisms: Streptococci; Enterococcus faecalis; Staphylococcus aureus. Patients ≥ 18 years. Exclusion Criteria: Known / suspected immunocompetence (HIV, chemotherapy, prednisolone treatment (> 20 mg / day)). Incapability to give informed consent for participation. Relapse Endocarditis (Endocarditis with the same bacteria within six months).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kasper K Iversen, MD
Phone
+4528712753
Email
kasper.k.iversen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Bundgaard, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Skejby Sygehus
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Wiggers, MD
Email
henrikwiggers@dadlnet.dk
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henning Bundgaard
Facility Name
Gentofte Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Bruun, MD
Email
n.eske.b@dadlnet.dk
Facility Name
Herlev Hoslpital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kasper Iversen
Email
kasper.iversen@dadlnet.dk
Facility Name
Hillerød Hospital
City
Hillerød
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Tønder
Email
nito@0regionh.dk
Facility Name
Odense Sygehus
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Gill, MD
Email
sabine.gill@dadlnet.dk
Facility Name
Roskilde Sygehus
City
Roskilde
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne Elming
Email
hei@regionsjaelland.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Accelerated Treatment of Endocarditis

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