Partial Oral Treatment of Endocarditis

Phase 4

Completed

• Conditions: Endocarditis
• Interventions: Drug: Guideline treatment with parenteral antibiotics; Drug: Oral treatment with antibiotics for endocarditis

• Registration Number: NCT01375257
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Study Start: 2011-07
• Primary Completion: 2017-08-30
• Study Completion: 2017-08-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-09
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guideline treatment with parenteral antibiotics	Guideline treatment with parenteral antibiotics	Guideline treatment with parenteral antibiotics
Oral treatment with antibiotics	Oral treatment with antibiotics for endocarditis	Oral treatment with antibiotics based on resistens pattern

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cost of treatment	Approximately 7 months. From randomisation until 6 months after end of study medication
Complications related to intravenous catheter	6 weeks
Duration of antibiotic therapy	Approximately 7 months. From randomisation until 6 months after end of study medication
Quality of life	Approximately 7 months. From randomisation until 6 months after end of study medication	QOL performed during the study and after completion of the study

Trial Locations

Locations (8)

Gentofte Hospital; 🇩🇰 Copenhagen, Denmark

Herlev Hoslpital; 🇩🇰 Copenhagen, Denmark

Roskilde Sygehus; 🇩🇰 Roskilde, Denmark

Skejby Sygehus; 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Aalborg Sygehus; 🇩🇰 Aalborg, Denmark

Odense Sygehus; 🇩🇰 Odense, Denmark

Hillerød Hospital; 🇩🇰 Hillerød, Denmark