NCT03851575

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

4.4 years

First QC Date

December 3, 2018

Last Update Submit

February 4, 2020

Conditions

Infectious Endocarditis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Quality of life

    6 monts after randomization and after

  • Expenses

    6 monts after randomization

  • Duration of hospitalization

    6 monts after randomization

  • Death

    6 monts after randomization

  • Embolisms

    6 monts after randomization

  • +2 more secondary outcomes

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Usual guideline therapy

Other: Usual guideline therapy

Accelerated arm

EXPERIMENTAL

Accelerated treatment of endocarditis

Other: Accelerated treatment of endocarditis

Interventions

Accelerated treatment of endocarditisOTHER

For the three main bacteria species we shorten the duration of antibiotic treatment

Accelerated arm
Usual guideline therapyOTHER

Usual guideline therapy

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Skejby Sygehus

Aarhus, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Gentofte Hospital

Copenhagen, Denmark

RECRUITING

Herlev Hoslpital

Copenhagen, Denmark

RECRUITING

Hillerød Hospital

Hillerød, Denmark

RECRUITING

Odense Sygehus

Odense, 5000, Denmark

RECRUITING

Roskilde Sygehus

Roskilde, Denmark

RECRUITING

MeSH Terms

Conditions

Endocarditis, Subacute Bacterial

Condition Hierarchy (Ancestors)

Endocarditis, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsCardiovascular InfectionsCardiovascular DiseasesEndocarditisHeart Diseases

Study Officials

  • Henning Bundgaard, MD

    Rigshospitalet, Denmark

    STUDY CHAIR

Central Study Contacts

Kasper K Iversen, MD

CONTACT

+4528712753kasper.k.iversen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 3, 2018

First Posted

February 22, 2019

Study Start

January 17, 2019

Primary Completion

June 10, 2023

Study Completion

December 10, 2023

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

DK(7)