Short vs Long of Usual Treatment for Non Complicated Enterococcal Bacteremia

NCT05394298 | Unknown Phase 4 DMC

• 2 other identifiers: RCT- INTENSE2021-003891-15
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 22

Brief 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

Keywords

Enterococcus; Bacteremia

Outcome Measures

Primary Outcomes (1)

• Clinical success

  Clinical success , composite endpoint defined as all the following: (a) survival at TOC; (b) absence of enterococcal bacteremia relapse or infective endocarditis diagnosis at TOC; (c) no need to prolong therapy beyond the pre-established duration, or restart drugs against enterococci for any reason within 30 days.

  TOC (Test of cure) visit (performed at day 28-32 after the end of suitable antibiotic treatment) or if drainage occurs after day 7 of treatment, TOC is to be done 7 days after that day.

Secondary Outcomes (8)

• Rates of relapse or infective endocarditis diagnosis

  TOC visit (day 28-32 ) and follow-up visit at day 90

• Survival

  TOC visit (day 28-32) and follow-up visit at day 90

• Length of hospital stay

  From patient first day inhospital (day of admission) until patient hospital discharge due to cure or home follow up assessed up to 30 days of the initiation of antibiotic administration

• Duration of intravenous and total therapy

  From date of randomization until the last follow up visit planned 30 days of the initiation of antibiotic administration

• Incidence of diarrhoea by C. difficile

  From date of randomization until the last follow up visit planned 30 days of the initiation of antibiotic administration

Study Arms (2)

Short-treatment of any active antibiotic regimen

EXPERIMENTAL

7 days from the initiation of an appropriate antimicrobial therapy and documented resolution of bacteremia (negative control blood cultures performed on day 2 or 3)

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

Long-treatment of any active antibiotic regimen

ACTIVE COMPARATOR

14 days of any active antibiotic treatment from the date of the last positive blood culture and documented resolution of bacteremia (negative control blood cultures performed on day 2 or 3)

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

Interventions

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

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

Also known as: 7 days of active antibiotics

Short-treatment of any active antibiotic regimen

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

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

Also known as: 14 days of active antibiotics

Long-treatment of any active antibiotic regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years of age or older) hospitalised with monomicrobial E. faecalis or E. faecium bacteremia.
• Negative follow-up blood cultures performed between days 2 and 3 of active treatment.
• Disappearance of fever (\>37.8ºC) within the first 72 hours.
• Signed informed consent.

You may not qualify if:

• patients with polymicrobial bacteremia
• Patients with limited life expectancy in whom only conservative clinical management had been decided.
• Hemodynamic instability on day 5-6 after the start of active treatment.
• Patients wearing endovascular devices or prosthetic heart valves.
• Source of uncontrolled bacteremia adequately defined as undrained abscess, bile duct infection associated with plastic prostheses not removed or not replaced within the first 72 hours of bacteraemia, other infections related to non-removed prostheses, prostatitis, and infective endocarditis, as well as infections that require prolonged treatment, such as joint and bone infections.
• Existence of a secondary focus, different from the initial one, or presence of metastatic focus of infection.
• Severe neutropenia (\<500 cells / mm3) at the time of bacteremia diagnosis.
• Pregnancy and lactation.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Spanish Network for Research in Infectious Diseases: collaborator
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (22)

COMPLEJO Universitario de La Coruña

A Coruña, A Coruña, 15006, Spain

RECRUITING

Hospital Universitario Torrecárdenas

Almería, Almeria, 04009, Spain

RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Hospital de Cruces

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

Hospital Universitario de Jerez de La Frontera

Jerez de la Frontera, Cadiz, 11408, Spain

RECRUITING

Hospital Universitario de Puerto Real

Puerto Real, Cadiz, 11510, Spain

NOT YET RECRUITING

Hospital Universitario de Jaén

Jaén, JAEN, 23007, Spain

RECRUITING

Hospital Universitario Costa Del Sol

Marbella, Malaga, 29603, Spain

RECRUITING

Hospital Universitario Regional de Málaga

Málaga, Malaga, 29010, Spain

RECRUITING

Hospital Universitario de Vigo

Vigo, Pontevedra, 36312, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

RECRUITING

Hospital Universitario Juan Ramón Jiménez

Huelva, 210101, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Complejo Hospitalario Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

NOT YET RECRUITING

Hospital Universitario de Donostia

San Sebastián, 20014., Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario Virgen Del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Universitario Virgen de Valme

Seville, 410303, Spain

RECRUITING

Related Publications (1)

• Maldonado N, Rosso-Fernandez CM, Portillo-Calderon I, Borreguero Borreguero I, Tristan-Clavijo E, Palacios-Baena ZR, Salamanca E, Fernandez-Cuenca F, De-Cueto M, Stolz-Larrieu E, Rodriguez-Bano J, Lopez-Cortes LE. Randomised, open-label, non-inferiority clinical trial on the efficacy and safety of a 7-day vs 14-day course of antibiotic treatment for uncomplicated enterococcal bacteraemia: the INTENSE trial protocol. BMJ Open. 2023 Sep 6;13(9):e075699. doi: 10.1136/bmjopen-2023-075699.

  PMID: 37673453 DERIVED

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis Eduardo López Cortés

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara María Rosso Fernández

CONTACT

0034 955 013414; claram.rosso.sspa@juntadeandalucia.es

Irene Borreguero Borreguero

CONTACT

+34955007609; irene.borreguero@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, multicentre, phase IV open trial of real clinical practice

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 27, 2022
• Study Start: July 11, 2022
• Primary Completion: July 15, 2024
• Study Completion: December 15, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From starting to three years of study completion planification
• Access Criteria: Spanish Network for Research in Infectious Disease investigators

Locations

ES (22)