Partial Oral Treatment of Endocarditis (POET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Rigshospitalet, Denmark
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01375257
First received: June 13, 2011
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

Background Current management of infective endocarditis include admission and treatment with parenteral antibiotics for 4 weeks - 6 weeks. Resource demands and psychological issues of present management strategy make it highly relevant to seek for alternative more lenient alternatives. Experiences with oral treatment are only sporadically described, but observational data suggest that oral treatment could be a feasible option. The investigators have in 2010 treated 12 endocarditis patients with partial oral antibiotics with a 100% success rate.

Study design The POET study is a Danish multicenter, prospective, randomized, open label study. The primary aim is to show non-inferiority of partial oral treatment with antibiotics of endocarditis compared to full parenteral treatment. Stable patients (n=400) with streptococci, staphylococci or enterococci infecting the mitral valve or the aortic valve will be included. After a minimum of 10 days of parenteral treatment, patients will be randomized to oral therapy or parenteral therapy. Special recommendations for oral treatment have been developed based on expected minimal inhibitory concentrations and pharmacokinetic calculations. Patients will be followed for 6 months after completion of antibiotic therapy. The primary endpoint is a composition of all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen.


Condition Intervention Phase
Endocarditis
Drug: Oral treatment with antibiotics for endocarditis
Drug: Guideline treatment with parenteral antibiotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Partial Oral Treatment of Endocarditis

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • The primary endpoint is a composite endpoint including all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ] [ Designated as safety issue: No ]
    QOL performed during the study and after completion of the study

  • Cost of treatment [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ] [ Designated as safety issue: No ]
  • Duration of antibiotic therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of cerebral infarcts [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ] [ Designated as safety issue: No ]
  • Complications related to intravenous catheter [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Guideline treatment with parenteral antibiotics Drug: Guideline treatment with parenteral antibiotics
Experimental: Oral treatment with antibiotics Drug: Oral treatment with antibiotics for endocarditis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Left-sided endocarditis based on the Duke criteria
  • Infected with one of the following microorganisms:

    • Streptococci
    • Enterococcus faecalis
    • Staphylococcus aureus
    • Coagulase-negative staphylococci.
  • ≥ 18 years
  • At least 10 days of appropriate parenteral antibiotic treatment overall, and at least 1 week of appropriate parenteral treatment after valve surgery
  • Afebrile (T < 38.0) > 2 days
  • Decreasing infection parameters (CRP dropped to less than 25% of peak value or < 20 mg/l, and white blood cell count < 15 x 109/l) during antibiotic treatment
  • No sign of abscess formation by echocardiography
  • Transthoracic and transoesophageal echocardiography performed within 48 hours prior to randomization

Exclusion Criteria:

  • Body mass index > 40
  • Concomitant infection requiring intravenous antibiotic therapy
  • Inability to give informed consent to participation
  • Suspicion of reduced absorption of oral treatment due to abdominal disorder
  • Reduced compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375257

Contacts
Contact: Kasper Iversen, MD 0045 35459863 kasper.iversen@dadlnet.dk

Locations
Denmark
Aalborg Sygehus Not yet recruiting
Aalborg, Denmark
Contact: Eva Korup       eva.korup@gmail.com   
Skejby Sygehus Not yet recruiting
Aarhus, Denmark, 8200
Contact: Henrik Wiggers, MD       henrikwiggers@dadlnet.dk   
Gentofte Hospital Not yet recruiting
Copenhagen, Denmark
Contact: Niels Bruun, MD       n.eske.b@dadlnet.dk   
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Iversen         
Odense Sygehus Not yet recruiting
Odense, Denmark, 5000
Contact: Sabine Gill, MD       sabine.gill@dadlnet.dk   
Roskilde Sygehus Not yet recruiting
Roskilde, Denmark
Contact: Hanne Elming       hei@regionsjaelland.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01375257     History of Changes
Other Study ID Numbers: Endocarditis-DK
Study First Received: June 13, 2011
Last Updated: June 16, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Endocarditis
Cardiovascular Diseases
Heart Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014