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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05398289
Other study ID # FST_2022
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2024
Est. completion date September 1, 2026

Study information

Verified date May 2023
Source University Magna Graecia
Contact Alessandro Russo, Prof.
Phone +39 09613647552
Email a.russo@unicz.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Duration of therapy in severe infections has a high impact in term of compliance, adverse events, and costs but also in term of antibiotic pressure on selection of multidrug-resistant pathogens. In this context, many advancements have been obtained for an early diagnosis of IE with a strict selection of criteria for surgery. Moreover, the use in antibiotic regimen of new drugs with peculiar PK/PD characteristics, as a quick bactericidal action, also for IE was not accompanied to a revaluation of duration of antibiotic treatment. On this basis, US and European guidelines recommend a 6-week duration of antibiotic treatment for IE due to enterococcal species. AIM 1: To evaluate a 4-week duration of antibiotic therapy versus a 6-week duration according to international guidelines. AIM 2: Second aim is to evaluate the PK/PD of antimicrobials in relation to the probability of target attainment (PTA) of optimal exposure against enterococci. AIM 3: Finally, we will analyze the bactericidal activities of antibiotic combinations used in patients with IE and the survival of the subgroup of patients who underwent surgery. Open-label, multicenter, randomized, non-inferiority trial to be conducted in a 3-year period. The institutional review board at each site will approve the protocol, and all patients or their authorized representatives will provide written informed consent. Eligible patients will be 18 years of age or older with a documented IE due to enterococcal strains, according to the modified Duke criteria. 63 patients in each of the two arms. The study will be conducted at Italian sites. Data on demographic characteristics, comorbidities, antibiotic and concomitant therapies will be collected. Baseline treatments will be defined according to the patients' pharmacological history. IE will be defined according to modified Duke criteria. Antibiotic treatment, indications and timing of surgery will be based on the 2015 American Heart Association and European Society of Cardiology guidelines. Blood samples for determining antibiotic concentrations of ampicillin, gentamicin, vancomycin, daptomycin and linezolid will be collected at predetermined times in order to allow estimation of PK/PD. Randomization: 1. 4-week duration of antibiotic therapy 2. standard 6-week duration of antibiotic therapy The intention-to-treat population (ITT) will include all randomized patients. The modified intention-to-treat population (mITT) will include all randomized patients receiving at least one dose of study medication. The clinically evaluable (CE) population will include ITT patients demonstrating sufficient adherence to study protocol. Primary endpoint: non-inferiority of a 4-week course in terms of outcome at 60 days. Secondary endpoints: microbiological eradication, pharmacological concentrations of antibiotic regimens, patients undergoing surgery, duration of therapy according with resistance profile of enterococcal species.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date September 1, 2026
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - documented infective endocarditis due to enterococcal strains, according to the modified Duke criteria. Exclusion Criteria: - patients candidate for chronic suppressive antibiotic treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
4-week duration of antibiotic therapy
The aim is to show non-inferiority of a 4-week duration of antibiotic therapy versus a standard 6-week duration according to international guidelines
6-week duration of antibiotic therapy
The aim is to show non-inferiority of a 4-week duration of antibiotic therapy versus a standard 6-week duration according to international guidelines

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Magna Graecia

Outcome

Type Measure Description Time frame Safety issue
Primary A 4-week course of effective antimicrobial therapy To evaluate clinical cure after 4 weeks of therapy at 30 days and after 60 days from enrollment
Secondary Microbiological clearance of Enterococcus spp from blood cultures Time to microbiological clearance from blood From inclusion, up to 30 days
Secondary Surgical Procedure Time to surgery From inclusion, up to 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT04070820 - Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"