A Phase 4 interventional study of Short-treatment of any active antibiotic regimen 7 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia. and Long-treatment of any active antibiotic regimen 14 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia. in Enterococcal Bacteremia, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Recruiting at 22 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Phase 4, Interventional, and Treatment
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.
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.
Adequate antibiotic regimen is included in the protocol; initially this regimen included ciprofloxacine but this has been modified si that in the last version 3 dated feb 6th ciprofloxacine is not allowed as a possible treatment for these patients.
Antibiotic regimen included as possible treatments in the study are the follows:
Intra-abdominal or soft tissue infections meeting study criteria, for which a polymicrobial infection is suspected:
Amoxicillin/clavulanic acid (isolates sensitive to ampicillin) 1 g/8h iv - Piperacillin/tazobactam (isolates sensitive to ampicillin) 4 g/8h (i.v.) - Combination of vancomycin, linezolid or daptomycin with a drug active against Gram-negative and anaerobic bacteria to ensure complete coverage in the case of bacteremia with a presumably polymicrobial focus.
Oral Treatment: In order to facilitate discharge of patients in both arms and reduce the risk of complications, as well as in keeping with the increasing use of this practice, the option to switch to oral therapy is allowed at the discretion of the responsible clinician, in both arms in patients with hemodynamic stability who tolerate oral treatment, at the discretion of the physician.
responsable.
The previous version allowed the use of cipro at the discretion of the clinicians as a sequential treatment option based on the fact that it is a clinical trial for low-risk bacteraemias in order to facilitate early sequential treatment (and thus avoid unnecessarily prolonging the hospital admissions.We decided to withdraw it on the basis that currently the EUCAST breakpoints only apply to urinary tract infections.The direct consequence is that the number of sequential treatment options is reduced.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 284 is above the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The previous version allowed this inclusion criterion "Early adequate control of the source of bacteremia within 72 hours in the cases in which it is feasible and necessary (urinary or biliary tract release; abscess drainage; catheter-removal, etc)", which is now removed because it is already an exclusion criterion.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
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
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.
Time frame: 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.
Rates of relapse or infective endocarditis diagnosis
Rates of relapse or infective endocarditis diagnosis in the CEP (Clinically Evaluable Population)
Time frame: TOC visit (day 28-32 ) and follow-up visit at day 90
Survival
Number of live patients
Time frame: TOC visit (day 28-32) and follow-up visit at day 90
Length of hospital stay
Number of days patient is in-hospital
Time frame: 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
Number of days of intravenous and total therapy in the CEP (Clinically Evaluable Population)
Time frame: 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
To evaluate the frequency of diarrhea by C. difficile
Time frame: From date of randomization until the last follow up visit planned 30 days of the initiation of antibiotic administration
Number of participants with Adverse Events due to antibiotic treatment
Registration of all adverse events happening form the signature on informed consent form to 30 days after the study drugs administration.
Time frame: From date of randomization until the last follow up visit planned 90 days of the initiation of antibiotic administration
Incidence of secondary infections
Number of patients with recurrent bacteremia
Time frame: TOC visit (on day 28-32) and follow-up visit at day 90
Change in SOFA score (Sepsis related Organ Failure Assessment)
Calculation of the SOFA score valued from 0 to 4 (0 best to 4 worst punctuation)
Time frame: Visit 0 (baseline) and TOC visit (on day 28-32) and follow-up visit at day 90
Plan to share: Yes — Planning for the study will be shared with potential sites pertaining to Spanish Network for Research in Infectious Disease (REIPI)for participation. IPD is not foreseen out of this groups due to the specific characteristics of patients and sites to be candidates for study participation.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: From starting to three years of study completion planification
Access criteria: Spanish Network for Research in Infectious Disease investigators
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for Jul 2024, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla →