Antibiotic treatment for patients with infectious endocarditis: continuous infusion, guided by measurements of the antibiotic concentration in the blood, versus intermittent infusions (the CONTENT study).

• Conditions: Infectious Endocarditis; MedDRA version: 16.1Level: LLTClassification code 10000667Term: Acute and subacute infective endocarditis in diseases classified elsewhereSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002807-32-DK
• Lead Sponsor: Aarhus University Hospital, Department of Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-03
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Verified infectious endocarditis, with bacteria in the blood, susceptible for either Benzylpenicillin or Diclocil.
2. Less than 96 hours since the onset of intra venous antibiotic treatment.
3. Use of contraception (for fertile women)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Negative blood cultures.
2. More than 96 hours since the onset of intra venous antibiotic treatment.
3. Planned valve surgery.
4. Planned extraction of a pace maker.
5. Allergy to Benzylpenicillin or Diclocil.
6. Unability to understand information about the study and to give informed consent.
7. Age under 18.
8. Preagnancy.
9. Breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified