Enterococcal BacteremiaPhase 4INTENSENCT05394298
Short vs Long of Usual Treatment for Non Complicated Enterococcal Bacteremia
A Phase 4 study testing 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 people with Enterococcal Bacteremia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 22 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterococcal Bacteremia
- What is being tested?
- 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 22 sitesSpain
- Study dates
- 11 Jul 2022to 15 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites, 22 recruiting
- Recruiting
COMPLEJO Universitario de La Coruña
A Coruña, A Coruña, 15006
Lucía Ramos Merino, MD
- Recruiting
Hospital Universitario Torrecárdenas
Almería, Almeria, 04009
Maria Angeles Esteban Moreno, MD
- Recruiting
Hospital de Cruces
Barakaldo, Bizkaia, 48903
Ane Josune Goikoetxea Aguirre, MD
- Recruiting
Hospital del Mar
Barcelona, 08003
Silvia Castañeda Espinosa, MD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Joaquín López-Contreras González, MD
- Recruiting
Hospital Universitario Virgen de Las Nieves
Granada, 18014
Miguel Angel Lopez Ruz, MD
- Recruiting
Hospital Universitario Juan Ramón Jiménez
Huelva, 210101
Francisco Martinez Marcos, MD
- Recruiting
Hospital Universitario de Jaén
Jaén, JAEN, 23007
Maria Carmen Herrero Rodriguez, MD
- Recruiting
Hospital Universitario de Jerez de La Frontera
Jerez de la Frontera, Cadiz, 11408
Salvador Lopez Cardenas, MD
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Francesca Gioia Gioia, MD
- Recruiting
Hospital Universitario Regional de Málaga
Málaga, Malaga, 29010
Antonio Plata Ciézar, MD
- Recruiting
Hospital Universitario Costa Del Sol
Marbella, Malaga, 29603
Alfonso Del Arco Jimenez, MD
- Not yet recruiting
Complejo Hospitalario Universitario Virgen de la Arrixaca
Murcia, 30120
Encarnación Moral Escudero, MD
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Helem Haydee Vilchez Rueda, MD
- Not yet recruiting
Hospital Universitario de Puerto Real
Puerto Real, Cadiz, 11510
Patricia Jimenez Aguilar, MD
- Recruiting
Hospital Universitario de Donostia
San Sebastián, 20014.
Maialen Ibarguren Pinilla, MD
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Carmen Fariñas Alvarez, MD
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Luis Eduardo Lopez Cortes, MD
- Recruiting
Hospital Universitario Virgen Del Rocío
Seville, 41013
María Panyagua, MD
- Recruiting
Hospital Universitario Virgen de Valme
Seville, 410303
Pedro María Martinez Perez-Crespo, MD
- Recruiting
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, 08221
Laura Marina Gisbert Perez, MD
- Recruiting
Hospital Universitario de Vigo
Vigo, Pontevedra, 36312
Rebeca Longueira Suarez, MD
About this study
Official title: Randomized Non-inferiority Clinical Trial to Evaluate the Effectiveness and Security of Therapy for Non Complicated Enterococcal Bacteremia.
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.
Read the detailed description
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:
- Isolated strains sensitive to ampicillin: ampicillin 2g/6 or 8h (i.v)
- Strains resistant to ampicillin and/or patients with allergy to beta-lactam drugs:
- Vancomycin: 15 mg/kg/12h i.v (with determination of trough plasma levels on day 2-3 of treatment if available).
- Linezolid: 600 mg/12 hours (i.v)
- Daptomycin: 8-10 mg/kg/day (i.v).
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.
- Amoxicillin 1g/8h or amoxicillin/clavulanic acid 875/125mg/8h if polymicrobial infection is suspected Linezolid 600mg/12h The choice will be in this order, according to the sensitivity of the isolate and allergies or other common circumstances for the use of these drugs.
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.
- Conditions
- Enterococcal Bacteremia
- Being tested
- 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 14 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.
- Keywords
- Enterococcus, Bacteremia
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-treatment of any active antibiotic regimen 7 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.Drug
Also called 7 days of active antibiotics
Any active antibiotic with treatment with proven in vitro activity from a pre-stablished list of antibiotics included
Long-treatment of any active antibiotic regimen 14 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.Drug
Also called 14 days of active antibiotics
Any active antibiotic with treatment with proven in vitro activity a pre-stablished list of antibiotics included
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Long-treatment of any active antibiotic regimen 14 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Rates of relapse or infective endocarditis diagnosis in the CEP (Clinically Evaluable Population)
Measured: TOC visit (day 28-32 ) and follow-up visit at day 90
Survival
Number of live patients
Measured: TOC visit (day 28-32) and follow-up visit at day 90
Length of hospital stay
Number of days patient is in-hospital
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: Visit 0 (baseline) and TOC visit (on day 28-32) and follow-up visit at day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start11 Jul 2022
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enterococcal BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, multicentre, phase IV open trial of real clinical practice
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Network for Research in Infectious Diseases, Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- Luis Eduardo López Cortés, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394298
- Sponsor's protocol ID
- RCT- INTENSE
- Other IDs
- 2021-003891-15
- Acronym
- INTENSE
- Status last verified
- May 2023
- First submitted
- 11 Apr 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37673453
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non-inferiority Clinical Trial to Evaluate the Effectiveness and Security of Therapy for Non Complicated Enterococcal Bacteremia.
- ClinicalTrials.gov ID
- NCT05394298
- Acronym / sponsor ID
- INTENSE / RCT- INTENSE
- Conditions
- Enterococcal Bacteremia
- Keywords
- Enterococcus, Bacteremia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Spanish Network for Research in Infectious Diseases, Spanish Clinical Research Network - SCReN
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Isolated strains sensitive to ampicillin: ampicillin 2g/6 or 8h (i.v)
- Strains resistant to ampicillin and/or patients with allergy to beta-lactam drugs:
- Vancomycin: 15 mg/kg/12h i.v (with determination of trough plasma levels on day 2-3 of treatment if available).
- Linezolid: 600 mg/12 hours (i.v)
- Daptomycin: 8-10 mg/kg/day (i.v).
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.
- Amoxicillin 1g/8h or amoxicillin/clavulanic acid 875/125mg/8h if polymicrobial infection is suspected Linezolid 600mg/12h The choice will be in this order, according to the sensitivity of the isolate and allergies or other common circumstances for the use of these drugs.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, multicentre, phase IV open trial of real clinical practice
| Arm | Type | Receives |
|---|---|---|
| Short-treatment of any active antibiotic regimen | Experimental | Drug: Short-treatment of any active antibiotic regimen 7 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.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) |
| Long-treatment of any active antibiotic regimen | Active comparator | Drug: Long-treatment of any active antibiotic regimen 14 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-treatment of any active antibiotic regimen 7 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.Also: 7 days of active antibioticsAny active antibiotic with treatment with proven in vitro activity from a pre-stablished list of antibiotics included | Drug | 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.Also: 14 days of active antibioticsAny active antibiotic with treatment with proven in vitro activity a pre-stablished list of antibiotics included | Drug | Long-treatment of any active antibiotic regimen |
Primary outcome
Clinical success
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.
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.
8 secondary outcomes
Rates of relapse or infective endocarditis diagnosis
Time frame: TOC visit (day 28-32 ) and follow-up visit at day 90
Survival
Time frame: TOC visit (day 28-32) and follow-up visit at day 90
Length of hospital stay
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
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
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
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
Time frame: TOC visit (on day 28-32) and follow-up visit at day 90
Change in SOFA score (Sepsis related Organ Failure Assessment)
Time frame: Visit 0 (baseline) and TOC visit (on day 28-32) and follow-up visit at day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 37673453Maldonado 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Eduardo López Cortés principal investigator
Hospital Universitario Virgen Macarena
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 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 people with Enterococcal Bacteremia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 22 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara María Rosso Fernández (0034 955 013414, claram.rosso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.