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).

Antibiotic treatment for patients with infectious endocarditis: continuous infusion, guided by therapeutic drug monitoring, versus intermittent infusions (the CONTENT study). - CONTENT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002807-32-DK

Enrollment

Registered

2013-09-03

Start date

2013-10-07

Completion date

Unknown

Last updated

2014-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Endocarditis MedDRA version: 16.1 Level: LLT Classification code 10000667 Term: Acute and subacute infective endocarditis in diseases classified elsewhere System Organ Class: 100000004862

Interventions

Trade Name: Benzylpenicillin Product Name: Benzylpenicillin Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: Benzylpenicillin CAS Number: 61-33-6 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if Benzylpenicillin and Diclocil, given as continuous infusion to patients with infectious endocarditis, leads to a bigger decline in C-reactive protein after 7 days of treatment, compared to Benzylpenicillin and Diclocil given as intermittent infusions to patients with infectious endocarditis.;Secondary Objective: To evaluate the effect of Benzylpenicillin and Diclocil, given as continuous infusion to patients with infectious endocarditis, on the following: • Decline in White blood cell count • Drop in body temperature • The concentration of antibiotics in blood plasma and comparison of this concentration to the Minimal Inhibitory Concentration (MIC). • The time the concentration of the given antibiotic remains above the MIC (in short, the T > MIC) • Side effects and complications due to the treatment. • Persisting blood stream infection during the first 3 days of treatment. • The size of valve vegetations at the start and at the end of the trial, examined by ultrasound. • The number of silent cerebral embolisms, valve oedema and valve destruction, at the start and at the end of the trial, examined by magnetic resonance. ;Primary end point(s): The decline in C-reactive protine, given in percentage, 7 days after the start of the trial. This will be compared between the patientes who recieve intermittent infusion and the patients who recieve continuous infusion.;Timepoint(s) of evaluation of this end point: 7 days	—

Measure

Time frame

Main Objective: To investigate if Benzylpenicillin and Diclocil, given as continuous infusion to patients with infectious endocarditis, leads to a bigger decline in C-reactive protein after 7 days of treatment, compared to Benzylpenicillin and Diclocil given as intermittent infusions to patients with infectious endocarditis.;Secondary Objective: To evaluate the effect of Benzylpenicillin and Diclocil, given as continuous infusion to patients with infectious endocarditis, on the following: • Decline in White blood cell count • Drop in body temperature • The concentration of antibiotics in blood plasma and comparison of this concentration to the Minimal Inhibitory Concentration (MIC). • The time the concentration of the given antibiotic remains above the MIC (in short, the T > MIC) • Side effects and complications due to the treatment. • Persisting blood stream infection during the first 3 days of treatment. • The size of valve vegetations at the start and at the end of the trial, examined by ultrasound. • The number of silent cerebral embolisms, valve oedema and valve destruction, at the start and at the end of the trial, examined by magnetic resonance. ;Primary end point(s): The decline in C-reactive protine, given in percentage, 7 days after the start of the trial. This will be compared between the patientes who recieve intermittent infusion and the patients who recieve continuous infusion.;Timepoint(s) of evaluation of this end point: 7 days

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Secondary

Measure	Time frame
Secondary end point(s): Potentially differences between the patients who recieve intermittent infusion, and the patientes who recieve continuous infusion, regarding: 1. Decline in white blood cell count. 2. Drop in body temperature. 3. The concentration of antibiotics in blood plasma and comparison of this concentration to the Minimal Inhibitory Concentration (MIC). 4. The time the concentration of the given antibiotic remains above the MIC (in short, the T > MIC) 5. Side effects and complications due to the treatment. 6. Persisting blood stream infection during the first 3 days of treatment. 7. The size of valve vegetations at the start and at the end of the trial, examined by ultrasound. 8. The number of silent cerebral embolisms, valve oedema and valve destruction, at the start and at the end of the trial, examined by magnetic resonance. ;Timepoint(s) of evaluation of this end point: 14 days.	—

Measure

Time frame

Secondary end point(s): Potentially differences between the patients who recieve intermittent infusion, and the patientes who recieve continuous infusion, regarding: 1. Decline in white blood cell count. 2. Drop in body temperature. 3. The concentration of antibiotics in blood plasma and comparison of this concentration to the Minimal Inhibitory Concentration (MIC). 4. The time the concentration of the given antibiotic remains above the MIC (in short, the T > MIC) 5. Side effects and complications due to the treatment. 6. Persisting blood stream infection during the first 3 days of treatment. 7. The size of valve vegetations at the start and at the end of the trial, examined by ultrasound. 8. The number of silent cerebral embolisms, valve oedema and valve destruction, at the start and at the end of the trial, examined by magnetic resonance. ;Timepoint(s) of evaluation of this end point: 14 days.

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Countries

Denmark

Contacts

Public ContactKristina Öbrink-Hansen

Aarhus University Hospital

krisoebr@rm.dk+4526 13 37 05

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026