Accelerated Treatment of Endocarditis (POETII)

February 4, 2020 updated by: Kasper Iversen, Rigshospitalet, Denmark
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control arm
Usual guideline therapy
Other: Usual guideline therapy
Usual guideline therapy
EXPERIMENTAL: Accelerated arm
Accelerated treatment of endocarditis
Other: Accelerated treatment of endocarditis
For the three main bacteria species we shorten the duration of antibiotic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary composite endpoint
Time Frame: 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).
6 monts after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Odense University Hospital
Zealand University Hospital
Aarhus University Hospital
Herlev Hospital
Lund University Hospital
Nordsjaellands Hospital

Investigators

  • Study Chair: Henning Bundgaard, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 17, 2019

Primary Completion (ANTICIPATED)

June 10, 2023

Study Completion (ANTICIPATED)

December 10, 2023

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

February 20, 2019

First Posted (ACTUAL)

February 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-18028566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infectious Endocarditis

Clinical Trials on Usual guideline therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe