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

June 13, 2011
June 16, 2011
June 2011
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01375257 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Partial Oral Treatment of Endocarditis
Partial Oral Treatment of Endocarditis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endocarditis
  • Drug: Oral treatment with antibiotics for endocarditis
  • Drug: Guideline treatment with parenteral antibiotics
  • Active Comparator: Guideline treatment with parenteral antibiotics
    Intervention: Drug: Guideline treatment with parenteral antibiotics
  • Experimental: Oral treatment with antibiotics
    Intervention: Drug: Oral treatment with antibiotics for endocarditis
Iversen K, Høst N, Bruun NE, Elming H, Pump B, Christensen JJ, Gill S, Rosenvinge F, Wiggers H, Fuursted K, Holst-Hansen C, Korup E, Schønheyder HC, Hassager C, Høfsten D, Larsen JH, Moser C, Ihlemann N, Bundgaard H. Partial oral treatment of endocarditis. Am Heart J. 2013 Feb;165(2):116-22. doi: 10.1016/j.ahj.2012.11.006. Epub 2013 Jan 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kasper Iversen, MD 0045 35459863 kasper.iversen@dadlnet.dk
Denmark
 
NCT01375257
Endocarditis-DK
Yes
Not Provided
Rigshospitalet, Denmark
Not Provided
Not Provided
Rigshospitalet, Denmark
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP