Partial Oral Treatment of Endocarditis

Endocarditis Clinical Trial

— POET  

Official title:

Partial Oral Treatment of Endocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375257
• Other study ID #: Endocarditis-DK
• Status: Completed
• Phase: Phase 4
• Start date: July 2011
• Est. completion date: August 30, 2017

Study information

• Verified date: March 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis

Intervention

Drug:
• Oral treatment with antibiotics for endocarditis

• Guideline treatment with parenteral antibiotics

Locations

Country	Name	City	State
Denmark	Aalborg Sygehus	Aalborg
Denmark	Skejby Sygehus	Aarhus
Denmark	Gentofte Hospital	Copenhagen
Denmark	Herlev Hoslpital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Hillerød Hospital	Hillerød
Denmark	Odense Sygehus	Odense
Denmark	Roskilde Sygehus	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Approximately 7 months. From randomisation until 6 months after end of study medication
Secondary	Quality of life	QOL performed during the study and after completion of the study	Approximately 7 months. From randomisation until 6 months after end of study medication
Secondary	Cost of treatment		Approximately 7 months. From randomisation until 6 months after end of study medication
Secondary	Duration of antibiotic therapy		Approximately 7 months. From randomisation until 6 months after end of study medication
Secondary	Complications related to intravenous catheter		6 weeks