Partial Oral Treatment of Endocarditis (POET)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Kasper Iversen, MD	0045 35459863	kasper.iversen@dadlnet.dk
Contact: Henning Bundgaard	0045 35450512

Locations

Denmark
Aalborg Sygehus	Recruiting
Aalborg, Denmark
Contact: Eva Korup eva.korup@gmail.com
Skejby Sygehus	Recruiting
Aarhus, Denmark, 8200
Contact: Henrik Wiggers, MD henrikwiggers@dadlnet.dk
Rigshospitalet	Recruiting
Copenhagen, Denmark, 2100
Contact: Iversen
Gentofte Hospital	Recruiting
Copenhagen, Denmark
Contact: Niels Bruun, MD n.eske.b@dadlnet.dk
Herlev Hoslpital	Recruiting
Copenhagen, Denmark
Contact: Kasper Iversen kasper.iversen@dadlnet.dk
Hillerød Hospital	Recruiting
Hillerød, Denmark
Contact: Niels Tønder nito@0regionh.dk
Odense Sygehus	Recruiting
Odense, Denmark, 5000
Contact: Sabine Gill, MD sabine.gill@dadlnet.dk
Roskilde Sygehus	Recruiting
Roskilde, Denmark
Contact: Hanne Elming hei@regionsjaelland.dk

Sponsors and Collaborators

Rigshospitalet, Denmark

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Kasper Iversen, Consultant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT01375257 History of Changes
Other Study ID Numbers:	Endocarditis-DK
First Posted:	June 17, 2011
Last Update Posted:	July 24, 2017
Last Verified:	July 2017

Additional relevant MeSH terms:

Endocarditis; Heart Diseases; Cardiovascular Diseases; Anti-Bacterial Agents	Antibiotics, Antitubercular; Anti-Infective Agents; Antitubercular Agents