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Ramdomized non-inferiority clinical trial to evaluate the safety and efficacy of short duration therapy for non complicated enterococcal bacteremia.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508456-18-00
Acronym
INTENSE
Enrollment
284
Registered
2024-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-08

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

Conditions

Uncomplicated bacteremia caused by E. faecalis or E. faecium.

Brief summary

Clinical success at TOC in the ITTP.

Detailed description

Rates of diagnosis of relapse or infective endocarditis in OCD and follow-up visit in the clinically evaluable population (CEP)., Survival in OCD and follow-up visit., Length of hospital stay, Duration of IV and total therapy in CEP, Infection with C. difficile., Adverse events and severity, Secondary infections, Change in SOFA score in OCD and follow-up visit.

Interventions

DRUGVANCOMYCIN
DRUGLinezolid Normon 600 mg comprimidos recubiertos con película EFG
DRUGAMOXICILLIN
DRUGAMPICILLIN
DRUGDAPTOMYCIN
DRUGLINEZOLID
DRUGAmoxicilina/Ácido clavulánico Sandoz 1.000 mg/200 mg polvo para solución inyectable y para perfusión EFG
DRUGLinezolid 600 mg film-coated tablets

Sponsors

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Clinical success at TOC in the ITTP.

Secondary

MeasureTime frame
Rates of diagnosis of relapse or infective endocarditis in OCD and follow-up visit in the clinically evaluable population (CEP)., Survival in OCD and follow-up visit., Length of hospital stay, Duration of IV and total therapy in CEP, Infection with C. difficile., Adverse events and severity, Secondary infections, Change in SOFA score in OCD and follow-up visit.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026