Clinical trial to evaluate the safety and efficacy of a 7-day versus 14-day treatment for enterococcal infections.

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 CTR

Registry ID

EUCTR2021-003891-15-ES

Enrollment

284

Registered

2021-12-17

Start date

2022-02-21

Completion date

Unknown

Last updated

2022-03-02

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

Conditions

Adult patients with uncomplicated bacteremia caused by E. faecalis or E. faecium. MedDRA version: 20.1 Level: PT Classification code 10060945 Term: Bacterial infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Ciprofloxacin Product Name: Ciprofloxacin Pharmaceutical Form: Film-coated tablet + pessary Trade Name: ampicilin Product Name: ampicilin Pharmaceutical Form: Suspension for injection Tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients (18 years or older) hospitalized with E. faecalis or E. faecium bacteremia. - Adequate early control of the focus of bacteremia within 72 hours in the cases in which it is feasible and necessary - Negative control blood cultures performed between days 2-3 of treatment - Disappearance of fever (> 37.8ºC) in the first 72 hours. - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 241 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43

Exclusion criteria

Exclusion criteria: - Patients with limited life expectancy in whom only conservative clinical management had been decided. - Hemodynamic instability on day 5-6. - Patients wearing endovascular devices or heart valves prosthetics. - Outbreak of uncontrolled bacteremia adequately defined as abscess not drained, bile duct infection associated with plastic prostheses not removed or not replaced within the first 72 hours of bacteremia, other infections related to unremoved prostheses, prostatitis, and endocarditis infectious. - Existence of a secondary focus, different from the initial focus. - Severe neutropenia (<500 cells / mm3) at the time of diagnosis of bacteremia - Pregnancy and lactation.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): - Rates of diagnosis of relapse or infective endocarditis in OCD in the clinically evaluable population (CEP). - Survival in OCD - 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.;Timepoint(s) of evaluation of this end point: End points will be evaluated after treatment ends.	—

Measure

Time frame

Secondary end point(s): - Rates of diagnosis of relapse or infective endocarditis in OCD in the clinically evaluable population (CEP). - Survival in OCD - 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.;Timepoint(s) of evaluation of this end point: End points will be evaluated after treatment ends.

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Primary

Measure	Time frame
Main Objective: Demonstrate non-inferiority of a 7-day antibiotic treatment regimen over a 14-day regimen;Primary end point(s): Clinical success at TOC in the ITTP.;Timepoint(s) of evaluation of this end point: In the presence of non-drained abscess, the Healing Test will be performed on day 30 ± 2 after the end of the treatment or if the drainage occurs after the 7th day of treatment, the Healing Test will be performed 7 ± 2 days after that day .;Secondary Objective: - To evaluate the clinical response, length of hospital stay, relapse rate and presence of infective endocarditis. - To describe the efficacy of early oral sequential treatment. - To evaluate the frequency of diarrhea due to C. difficile. - To determine which microbiological factors influence the clinical course and the risk of relapse. - To assess security - To establish and test the definition of "uncomplicated enterococcal bacteremia"	—

Measure

Time frame

Main Objective: Demonstrate non-inferiority of a 7-day antibiotic treatment regimen over a 14-day regimen;Primary end point(s): Clinical success at TOC in the ITTP.;Timepoint(s) of evaluation of this end point: In the presence of non-drained abscess, the Healing Test will be performed on day 30 ± 2 after the end of the treatment or if the drainage occurs after the 7th day of treatment, the Healing Test will be performed 7 ± 2 days after that day .;Secondary Objective: - To evaluate the clinical response, length of hospital stay, relapse rate and presence of infective endocarditis. - To describe the efficacy of early oral sequential treatment. - To evaluate the frequency of diarrhea due to C. difficile. - To determine which microbiological factors influence the clinical course and the risk of relapse. - To assess security - To establish and test the definition of "uncomplicated enterococcal bacteremia"

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Countries

Spain

Contacts

Public ContactUICEC-HUVR

Unidad de Investigación Clínica y ensayos Clínicos

uicec.hvr.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 10, 2026