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| Name | Class |
|---|---|
| Spanish Clinical Research Network - SCReN | NETWORK |
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Phase IV, open-label, randomized and multicenter clinical trial to prove that patients with Enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard treatment, usually administered in hospitalized patients.
The aim of the study is to prove that the continuous infusion of antibiotic treatment for the patients with Enterococcus faecalis infective endocarditis is as effective and safe as the standard treatment. The continuous infusion modality of treatment is expected to provide numerous benefits for individual patients, global health, and for the National Health Care System by reducing to hospital stays from 4-6 weeks to approximately 2-3 weeks and hospital-driven complications.
The mortality, rate of serious adverse events, total number of days of antibiotic treatment and days of hospitalization, among others, are included as secondary objectives.
This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 365 days after the 42 days of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous intravenous antibiotic infusion | Experimental | Ampicillin 12g/24h plus ceftriaxone 4g/12h continuous infusion. The duration of treatment will be 42 days. |
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| Standard treatment | Active Comparator | Ampicillin 2g/4h plus ceftriaxone 2g/12h intermittent infusion for a minimum of 14 days. Starting on day 14 of treatment, if the patient is discharged from the hospital, the following treatments will be permitted:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampicillin plus ceftriaxone in continuous infusion | Drug | Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical failure | It is defined as follow: i) Confirmed recurrence of E. faecalis infective endocarditis, ii) all-cause mortality. A composite primary endpoint has been chosen to include both a very clinically relevant variable and a hard variable such as survival | One year after the end of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic failure | Number of deaths | Up to 12 months after treatment administration |
| Cardiac surgeries | Number of unplanned cardiac surgeries |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Herrera Hidalgo, MD-PhD | Contact | +34955013414 | lauraherrerahidalgo@gmail.com | |
| Clara M Rosso Fernández, MD-PhD | Contact | +34955013414 | claram.rosso.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| HUVR Cesar Arístides de Alarcón González, MD-PhD | Fundación para la Gestión de la Investigación en Salud de Sevilla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Álava | Recruiting | Alava | 01009 | Spain |
The results will be shared with the investigators involved in the study, and will be shared when the analysis of the results is performed.
6 months
Direct collaborators within the study
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Parallel Assignment Randomized 1:1 to experimental group (continuous infusion arm) or control group (intermittent infusion arm)
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| Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the treatment may be changed | Drug | Ampicillin plus ceftriaxone as an intermittent infusion for a minimum of 14 days. After, if the patient is discharged from the hospital, the following treatments, until the 42-day treatment period is completed:
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|
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| Up to 12 months after treatment administration |
| Readmissions | Number of unplanned readmissions | Up to 12 months after treatment administration |
| Adverse events | Number of medication-related adverse events | From randomisation until 30 days after the last dose administration |
| Antibiotic treatment days | Number of antibiotic treatment days | Up to 12 months after treatment administration |
| Outpatient Parenteral Antimicrobial Therapy | Number of Outpatient Parenteral Antimicrobial Therapy | Up to 12 months after treatment administration |
| Healthcare-associated infections | Number of healthcare-associated infections | Up to 12 months after treatment administration |
| Recurrence | Number of recurrence of Enterococcus faecalis infective endocarditis | Up to 12 months after treatment administration |
| Minimum free serum concentration | Minimum free serum concentration of antibiotics used | Day 14 |
| Steady-state plasma concentration | Steady-state plasma concentration of antibiotics used | Day 14 |
| Pharmacokinetic parameters | Volume of distribution, clearance, elimination constant of antibiotics used | Day 14 |
| Minimum Inhibitory Concentration | Minimum Inhibitory Concentration of ampicillin induced by ceftriaxone in the strains responsible for recurrences and control strains | Day 14 |
| Hospital Universitario de Cruces | Active, not recruiting | Barakaldo | 48903 | Spain |
| Hospital Universitario Vall d'Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
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| Hospital Clínico de Barcelona | Not yet recruiting | Barcelona | 08036 | Spain |
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| Hospital Universitario de Donostia | Active, not recruiting | Donostia / San Sebastian | 20014 | Spain |
| Hospital Universitario Virgen de las Nieves | Active, not recruiting | Granada | 18014 | Spain |
| Hospital San Pedro | Active, not recruiting | Logroño | 26006 | Spain |
| Hospital Universitario Gregorio Marañón | Active, not recruiting | Madrid | 28007 | Spain |
| Hospital Clínico San Carlos | Not yet recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario La Paz | Not yet recruiting | Madrid | 28046 | Spain |
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| Hospital Universitario Puerta del Hierro | Active, not recruiting | Madrid | 28222 | Spain |
| Hospital Universitario Regional de Málaga | Active, not recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de la Victoria | Active, not recruiting | Málaga | 29010 | Spain |
| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | 38320 | Spain |
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| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
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| Hospital Universitario Virgen Macarena | Active, not recruiting | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
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| Hospital Universitari MútuaTerrassa | Active, not recruiting | Terrassa | 08221 | Spain |
| ID | Term |
|---|---|
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D002443 | Ceftriaxone |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
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