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Accelerated treatment of heart valve infection

Accelerated treatment of infectious endocarditis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2022-001894-29-SE
Enrollment
750
Registered
2022-12-14
Start date
2023-01-16
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Infectious endocarditis

Interventions

Trade Name: Ceftriaxon Pharmaceutical Form: Powder and solvent for solution for infusion Trade Name: Doktacillin Product Name: Doktacillin Pharmaceutical Form: Powder and solution for solution for in

Sponsors

Lund University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Aged 18 years or older. Left-sided endocarditis caused by streptococci, Enterococcus faecalis, or Staphylococcus aureus. In-hopsital antibiotic treatment of less than 14 days duration. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Verified or suspected immunosuppression such as HIV-infektion, ongoing chemotherapy or systemic steroid treatment corresponding to > 20 mg prednisone per day. Unable to leave informed consent. Relapse of endocarditis defined as endocarditis caused by the same microorganism within 6 months after the previous infection. Endocarditis caused by Staphylococcus aureus in a patient with prostheic heart valve or a cardiovascular implanted device.

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate safety and effectiveness of shortening treatment of endocarditis.;Secondary Objective: To investigate the economic consequences of a shortened treatment of endocarditis.;Primary end point(s): a) dead b) septic embolization c) Bacteremia caused by the same microorganism d) Heart surgery not planned at randomization;Timepoint(s) of evaluation of this end point: Within 6 months from randomization.

Secondary

MeasureTime frame
Secondary end point(s): a) Costs of hopsital care and other treatment of the disease b) Lenghts of hospital stay c) Lenghts of antibiotic treatment d) Complications related to the intravenous access;Timepoint(s) of evaluation of this end point: Within 6 months from randomization.

Countries

Sweden

Contacts

Public ContactClinical Trials Information

Lund University

per.akesson@skane.se

Outcome results

None listed

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