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Efficacy and safety of Dalbavancin in the treatment of infective Endocarditis caused by gram-positive cocci

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526149-91-00
Enrollment
166
Registered
2026-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-30

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

Conditions

enterococci, Infectious endocarditis caused by Gram-positive cocci (staphylococci, streptococci)

Brief summary

Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy. Five possible DOOR ratings are distinguished: • Alive, no events • Alive, one event • Alive, two events • Alive, three events • Death within 90 days. Door events include: Cardiac surgery, Infectious complication, Embolic event

Detailed description

Health economic parameters at T90 (including length of hospital stay in days; costs of antibiotic therapy; number of days of work disability), Neurological outcome (National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) at Day 90 and 1 year, Health-related quality of life (PROMIS-29 domain-specific T-scores and pain intensity, EQ-5D-5L index and VAS, RNLI total score) at 90 days and 1 year, Overall mortality at 90 days and 1 year, Cardiac surgery at 90 days and 1 year, Infectious complications at 90 days and 1 year, Embolic event at 90 days and 1 year, Clinical Frailty Scale at 90 days and 1 year, Occurrence of treatment-related adverse events (T0 to EOT+14 days), Dalbavancin level determination and pharmacokinetic analysis (only patients in the intervention group) T1, T2, T14, and if applicable, T21/28/35, Microbiome analysis and resistance development (nasopharyngeal and rectal swabs/stool samples) T0, T90, and 1 year

Interventions

DRUGLEVOFLOXACIN
DRUGBENZYLPENICILLIN POTASSIUM
DRUGDOXYCYCLINE
DRUGDAPTOMYCIN
DRUGCIPROFLOXACIN
DRUGCEFOTAXIME
DRUGAMOXICILLIN
DRUGCEFTRIAXONE
DRUGMOXIFLOXACIN
DRUGFOSFOMYCIN
DRUGAMPICILLIN
DRUGDALBAVANCIN
DRUGRIFAMPICIN
DRUGCEFAZOLIN
DRUGIMIPENEM
DRUGLINEZOLID
DRUGVANCOMYCIN
DRUGMEROPENEM
DRUGTEICOPLANIN

Sponsors

Friedrich-Schiller-Universitaet Jena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy. Five possible DOOR ratings are distinguished: • Alive, no events • Alive, one event • Alive, two events • Alive, three events • Death within 90 days. Door events include: Cardiac surgery, Infectious complication, Embolic event

Secondary

MeasureTime frame
Health economic parameters at T90 (including length of hospital stay in days; costs of antibiotic therapy; number of days of work disability), Neurological outcome (National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) at Day 90 and 1 year, Health-related quality of life (PROMIS-29 domain-specific T-scores and pain intensity, EQ-5D-5L index and VAS, RNLI total score) at 90 days and 1 year, Overall mortality at 90 days and 1 year, Cardiac surgery at 90 days and 1 year, Infectious complications at 90 days and 1 year, Embolic event at 90 days and 1 year, Clinical Frailty Scale at 90 days and 1 year, Occurrence of treatment-related adverse events (T0 to EOT+14 days), Dalbavancin level determination and pharmacokinetic analysis (only patients in the intervention group) T1, T2, T14, and if applicable, T21/28/35, Microbiome analysis and resistance development (nasopharyngeal and rectal swabs/stool samples) T0, T90, and 1 year

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 1, 2026