E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Catheter bacteremia caused by coagulase-negative staphylococci. |
Bacteriemia de catéter causada por estafilococos coagulasa-negativa |
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E.1.1.1 | Medical condition in easily understood language |
Catheter infection caused by staphylococcal type bacteria. |
Infección del catéter causado por bacterias del tipo estafilococáceas. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054637 |
E.1.2 | Term | Staphylococcal bacteremia |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare in terms of efficacy and safety the strategy of not administering antibiotic treatment with that of treatment with antibiotic, in episodes of catheter bacteremia due to coagulase-negative staphylococci in patients without risk factors for complications. |
Comparar la estrategia de no administrar tratamiento antibiótico con el tratamiento estándar con antibiótico en cuanto a eficacia y seguridad, en los episodios de bacteriemia de catéter por estafilococos coagulasa-negativa en pacientes sin factores de riesgo para complicarse. |
|
E.2.2 | Secondary objectives of the trial |
To compare the two study arms in terms of: - Adverse events - Time to microbiological cure - Time to disappearance of fever - Costs derived from the treatment |
Comparar las dos estrategias del estudio en los episodios de bacteriemia de catéter por estafilococos coagulasa-negativa en pacientes sin factores de riesgo para complicarse en cuanto a: -Acontecimientos adversos - Tiempo hasta la curación microbiológica - Tiempo hasta la desaparición de fiebre - Costes derivados del tratamiento |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men and women over 18 years of age 2. Bacteremia due to coagulase-negative staphylococcal related to the venous catheter defined as detection of growth of coagulase-negative staphylococci (excluding S lugdunensis) in patients with a venous catheter, with the presence of clinical symptoms of infection and in the absence of other apparent foci of bacteremia, with the exception of the catheter itself. 3. Patients without risk factors for complications defined as absence of: septic shock, neutropenia (<500 Ne/uL), coagulase-negative staphylococci of the S lugdunensis type, moderate-severe valvular heart disease, artificial endovascular devices other than the catheter and signs of septic thrombophlebitis 4. Patients who have had the catheter removed within 24h prior to inclusion 5. Patients who have signed informed consent to participate in the study |
1. Hombres y mujeres mayores de 18 años 2. Bacteriemia por estafilococos coagulasa-negativa relacionada con el catéter venoso definida como detección de crecimiento de estafilococos coagulasa-negativa (excluyendo S lugdunensis) en un paciente portador de un catéter venoso, junto a la presencia de manifestaciones clínicas de infección y en ausencia de otros focos aparentes de la bacteriemia, exceptuando el propio catéter 3. Pacientes sin factores de riesgo de complicaciones definido como ausencia de: shock séptico, neutropenia (<500 Ne/uL), estafilococos coagulasa-negativa de la especie S lugdunensis, cardiopatía valvular moderada-severa, dispositivos artificiales endovasculares o extravasculares diferentes del catéter e indicios de tromboflebitis séptica 4. Pacientes a los que se haya retirado el catéter en las 48 horas previas a la inclusión 5. Pacientes que hayan firmado el consentimiento informado para participar en el estudio |
|
E.4 | Principal exclusion criteria |
1. Pregnant and breast-feeding patients 2. Patients who have not had the catheter removed 3. Patients with compromise of immunity 4. Hemodynamically unstable patients 5. Patients with prosthetic materials other than the catheter 6. Patients unable to give their informed consent freely or with inadequate cognitive capacity 7. Any circumstance that, at the discretion of the physician, may involve a risk or clinical detriment to the participation of the patient in the study or that interferes with the assessments of the same. |
1. Pacientes embarazadas y en periodo de lactancia 2. Pacientes a los que no se les haya retirado el catéter 3. Pacientes con compromiso de la inmunidad 4. Pacientes inestables hemodinámicamente 5. Pacientes con materiales protésicos diferentes al catéter 6. Pacientes incapaces de dar su consentimiento informado libremente o con capacidad cognitiva inadecuada 7. Cualquier circunstancia que, a criterio del médico, pueda suponer un riesgo o perjuicio clínico la participación del paciente en el estudio o que interfiera en las valoraciones del mismo |
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E.5 End points |
E.5.1 | Primary end point(s) |
A variable composed by the presence of persistent bacteremia, complicated bacteremia or the presence of any complication related to bacteremia or derived from the administration of antibiotics during the trial. |
Variable compuesta por la presencia de bacteriemia persistente, bacteriemia complicada o la presencia de cualquier complicación relacionada con la bacteriemia o derivada de la administración de los antibióticos durante el transcurso del seguimiento del estudio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Days 1, 2, 3, 4, 5, 6, 7 and every additional day until the resolution of bacteremia or end of treatment. |
Días 1, 2, 3, 4, 5, 6, 7 y todos los días adicionales hasta la resolución de la bacteriemia o fin del tratamiento. |
|
E.5.2 | Secondary end point(s) |
Presence of persistent bacteremia, complicated bacteremia, presence of any complication related to bacteremia or derived from the administration of antibiotics during the trial, time to microbiological cure, time to the disappearance of fever and costs derived from treatment. |
Presencia de bacteriemia persistente, bacteriemia complicada, presencia de cualquier complicacion relacionada con la bacteriemia o derivada de la administración de los antibióticos durante el transcurso del estudio, tiempo hasta la curación microbiológica, tiempo hasta la desaparición de la fiebre y costes derivados del tratamiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Days 1, 2, 3, 4, 5, 6, 7 and every additional day until the resolution of bacteremia or end of treatment. |
Días 1, 2, 3, 4, 5, 6, 7 y todos los días adicionales hasta la resolución de la bacteriemia o fin del tratamiento. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Antibióticos |
Antinfectious agents |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last patient last visit |
Ultima visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |