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Partial Oral Treatment of Endocarditis (POET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01375257
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kasper Iversen, Rigshospitalet, Denmark

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Endocarditis Drug: Oral treatment with antibiotics for endocarditis Drug: Guideline treatment with parenteral antibiotics Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Partial Oral Treatment of Endocarditis
Actual Study Start Date : July 2011
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : August 30, 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Guideline treatment with parenteral antibiotics
Guideline treatment with parenteral antibiotics
 Drug: Guideline treatment with parenteral antibiotics
Experimental: Oral treatment with antibiotics
Oral treatment with antibiotics based on resistens pattern
 Drug: Oral treatment with antibiotics for endocarditis


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ]
    QOL performed during the study and after completion of the study

  2. Cost of treatment [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ]
  3. Duration of antibiotic therapy [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ]
  4. Complications related to intravenous catheter [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375257


Locations
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Denmark
Aalborg Sygehus
Aalborg, Denmark
Skejby Sygehus
Aarhus, Denmark, 8200
Rigshospitalet
Copenhagen, Denmark, 2100
Gentofte Hospital
Copenhagen, Denmark
Herlev Hoslpital
Copenhagen, Denmark
Hillerød Hospital
Hillerød, Denmark
Odense Sygehus
Odense, Denmark, 5000
Roskilde Sygehus
Roskilde, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kasper Iversen, Consultant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01375257    
Other Study ID Numbers: Endocarditis-DK
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Endocarditis
Heart Diseases
Cardiovascular Diseases
Anti-Bacterial Agents
 Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents