Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"

Bloodstream Infection Clinical Trial

Official title:

"Combination Treatment for Enterococcus Faecalis Bacteremia: a Prospective, Multicenter, Observational Study"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070820
• Other study ID #: EfFAECT
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: March 2021

Study information

• Verified date: March 2020
• Source: University of Bologna
• Contact: Michele Bartoletti
• Phone: 0512143199
• Email: m.bartoletti[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI).

The aims of our study are:

Primary:

To compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care.

Secondary:

1. To compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. In this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy.

2. To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients:

A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score".

B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve.

3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI.

4. To estimate optimal duration of treatment of EF-BSI in patients without endocarditis.

5. To evaluate the rate of 90-day development of Clostridium difficile infection.

The promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form.

All consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients.

Period of data collection will be from september 2019 to 31th December 2020.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (>18 years)

• First monomicrobial EF-BSI

• Receipt of = 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin), at common suggested dosages for EF-BSI in empirical or definitive therapy

• Written informed consent

Exclusion Criteria:

• Short term (within 3 days from BSI) mortality

• Other concomitant infection

Related Conditions & MeSH terms

• Bacteremia
• Bloodstream Infection
• Communicable Diseases
• Endocarditis
• Enterococcal Bacteraemia
• Enterococcal Endocarditis
• Enterococcus Faecalis Infection
• Infection

Locations

Country	Name	City	State
Italy	Infectious Disease Unit - S.Orsola Malpighi Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (21)

Bouza E, Kestler M, Beca T, Mariscal G, Rodríguez-Créixems M, Bermejo J, Fernández-Cruz A, Fernández-Avilés F, Muñoz P; Grupo de Apoyo al Manejo de la Endocarditis. The NOVA score: a proposal to reduce the need for transesophageal echocardiography in patients with enterococcal bacteremia. Clin Infect Dis. 2015 Feb 15;60(4):528-35. doi: 10.1093/cid/ciu872. Epub 2014 Nov 7. Erratum in: Clin Infect Dis. 2015 May 21;:. — View Citation

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Rodríguez-Baño J, López-Prieto MD, Portillo MM, Retamar P, Natera C, Nuño E, Herrero M, del Arco A, Muñoz A, Téllez F, Torres-Tortosa M, Martín-Aspas A, Arroyo A, Ruiz A, Moya R, Corzo JE, León L, Pérez-López JA; SAEI/SAMPAC Bacteraemia Group. Epidemiology and clinical features of community-acquired, healthcare-associated and nosocomial bloodstream infections in tertiary-care and community hospitals. Clin Microbiol Infect. 2010 Sep;16(9):1408-13. doi: 10.1111/j.1469-0691.2009.03089.x. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Patient alive	End of Treatment, at least 2 weeks from first negative follow-up bloodculture
Primary	Body temperature (Celsius degrees)	Fever resolution	End of Treatment, at least 2 weeks from first negative follow-up bloodculture
Primary	Sequential Organ Failure Assessment (SOFA) Score	Stable or improved SOFA score. Total SOFA score ranges from 0 to 24 points. Total SOFA score consist of the sum of individual score of following items: Respiratory System (PaO2/FiO2), Cardiovascular system (Mean Arterial Pressure or administration vasopressure required), Newrvous System (Glasgow Coma Scale), Liver (bilirubin), Coagulation (platelets), Kidneys (creatinine). Each items receive a score ranging from 0 to 4 pt.	End of Treatment, at least 2 weeks from first negative follow-up bloodculture
Primary	Blood cultures	Follow-up Blood cultures negative for E. faecalis	End of Treatment, at least 2 weeks from first negative follow-up bloodculture
Primary	Blood cultures	No relapse of EF-BSI	90 days from End of Treatment
Primary	Antibiotic therapy	No need to modify initial therapy	90 days from End of Treatment