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Short vs Long of Usual Treatment for Non Complicated Enterococcal Bacteremia

NCT05394298 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2023-05-03

No results posted yet for this study

Summary

Randomized clinical trial to determine the optimal duration of antibiotic treatment for E. Faecalis or E. faecium bacteraemia, following an innovative DOOR / RADAR (Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)) analysis methodology.

Phase IV clinical trial, open-labelled, randomized, pragmatic, multicenter study to demonstrate non-inferiority of a 7-day antibiotic regimen vs. 14 days in the treatment of bacteremia due to E. faecalis or E. faecium.

Conditions

  • Enterococcal Bacteremia

Interventions

DRUG

Short-treatment of any active antibiotic regimen 7 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.

Any active antibiotic with treatment with proven in vitro activity from a pre-stablished list of antibiotics included

DRUG

Long-treatment of any active antibiotic regimen 14 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.

Any active antibiotic with treatment with proven in vitro activity a pre-stablished list of antibiotics included

Sponsors & Collaborators

  • Spanish Network for Research in Infectious Diseases

    collaborator OTHER

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Luis Eduardo López Cortés · Hospital Universitario Virgen Macarena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2024-07-15
Completion
2024-12-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394298 on ClinicalTrials.gov