E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
S. aureus bloodstream infections |
Sepsis por Staphylococcus aureus |
|
E.1.1.1 | Medical condition in easily understood language |
Blood infections, including heart valve infections |
Infecciones de la sangre, incluyendo infecciones de las válvulas cardíacas. |
|
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 | PT |
E.1.2 | Classification code | 10014665 |
E.1.2 | Term | Endocarditis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 | 10077008 |
E.1.2 | Term | Methicillin-sensitive Staphylococcus aureus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003997 |
E.1.2 | Term | Bacteraemia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 | 10041937 |
E.1.2 | Term | Staphylococcus aureus endocarditis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 | 10021839 |
E.1.2 | Term | Infection MRSA |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 | 10021881 - Infections and infestations |
|
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 describe the safety and tolerability of CF-301 vs. placebo in addition to SOC antibacterial therapy for the treatment of patients with S. aureus BSIs including right-sided endocarditis.
- To estimate clinical outcome at Day 14 after CF 301/placebo administration.
- To describe the PK parameters of CF-301. |
- Describir la seguridad y la tolerabilidad de CF-301 frente a placebo, añadido al tratamiento antibacteriano de referencia, para el tratamiento de pacientes con sepsis por Staphylococcus aureus con endocarditis que afecta al lado derecho.
- Estimar el resultado clínico el Día 14 después de la administración de CF-301 o placebo.
- Describir los parámetros farmacocinéticos (PK) de CF-301. |
|
E.2.2 | Secondary objectives of the trial |
- To estimate clinical outcome at Day 7 after CF-301/placebo administration, at the end of SOC antibacterial therapy (EOT), and at test-of-cure (TOC) 28 days after the EOT.
- To estimate microbiological response at Days 7 and 14 after CF-301/placebo administration.
- To estimate microbiological outcome at EOT and at TOC |
- Estimar el resultado clínico el Día 7 después de la administración de CF-301 o placebo, al finalizar el tratamiento antibacteriano de referencia (FdT), y en la prueba de curación (TOC) 28 días después de la visita de FdT.
- Estimar la respuesta microbiológica los Días 7 y 14 después de la administración de CF-301 o placebo.
- Estimar el resultado microbiológico en la visita de FdT y en la TOC. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, 18 years or older.
- Blood culture positive for S. aureus.
- At least one sign or symptom attributable to S. aureus bacteremia.
- Known or suspected right-sided endocarditis by Modified Duke Criteria and/or known or suspected complicated S. aureus BSI.
- Patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential. |
- Varones y mujeres a partir de 18 años de edad cumplidos.
- Hemocultivo positivo para S. aureus
- Como mínimo uno de los signos o síntomas atribuible a la bacteriemia de S. aureus.
- Documentación o sospecha de endocarditis que afecte al lado derecho, según los Criterios Modificados de Duke y / o documentación o sospecha de sepsis por S. aureus complicada.
- La paciente no está embarazada o en período de lactancia y no tiene capacidad reproductiva o acepta usar anticonceptivos si tiene capacidad reproductiva. |
|
E.4 | Principal exclusion criteria |
- Patient previously received CF-301.
- Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 48 hours within 7 days before randomization.
- Presence of any removable infection source that will not be removed or debrided within 72 hours after randomization.
- Presence of prosthetic joint or cardiac device.
- Known or suspected left-sided endocarditis, brain abscess, osteomyelitis or meningitis.
- Pneumonia or known polymicrobial bacteremia.
- Patient is employed by the sponsor or investigational site or is a first degree relative of a person employed by the sponsor or investigational site. |
- El paciente ha recibido anteriormente CF-301.
- Tratamiento con cualquier antibiótico sistémico (antiestafilocócico) potencialmente eficaz durante más de 48 horas en los 7 días antes de la aleatorización.
- Presencia de cualquier fuente de infección extirpable que no será retirado o desbridado en las 72 horas siguientes a la aleatorización.
- Presencia de prótesis articular o dispositivo cardiaco.
- Documentación o sospecha de endocarditis que afecta al lado izquierdo, de absceso cerebral, de osteomielitis o de meningitis.
- Neumonía o bacteriemia polimicrobiana conocida.
- El paciente es empleado del promotor o del centro de investigación o un familiar de primer grado de un empleado del promotor o del centro de investigación. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Safety and tolerability of CF-301 vs placebo in addition to standard-of-care antibacterial therapy.
- Clinical outcome at Day 14 after CF-301/placebo administration.
- Pharmacokinetic parameters of CF-301. |
- Seguridad y tolerabilidad de CF-301 vs placebo, además de tratamiento antibacteriano de referencia.
- Mejoría clínica o la respuesta el Día 14 después de la administración de CF-301 o placebo.
- Parámetros farmacocinéticos de CF-301. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Safety and tolerability of CF-301: Time of consent through test of cure
- Clinical outcome at Day 14 after CF-301/placebo administration
- PK parameters of CF-301: subsets of patients will give serial PK samples from either pre-dose through 48 hours, between 2.25 hours and 24 hours or 2.25 hours and 48 hours after the start of the study drug infusion |
- Seguridad y tolerabilidad de CF-301: Tiempo transacurrido desde el consentimiento hasta la prueba de curación.
- Mejoría clínica o la respuesta el Día 14 después de la administración de CF-301 o placebo.
- Parámetros farmacocinéticos de CF-301: subconjuntos de pacientes darán muestras seriadas de PK desde la pre-dosis hasta 48 horas, entre 2,25 horas y 24 horas o entre 2,25 horas y 48 horas después del inicio de la infusión del fármaco del estudio. |
|
E.5.2 | Secondary end point(s) |
- Clinical outcome at Day 7 after CF301/placebo administration.
- Clinical outcome at the end of SOC antibacterial therapy (EOT), and at test of cure (TOC), and 28 days after EOT.
- Microbiological response.
- Microbiological outcome. |
- Resultado clínico al día 7 después de la administración de CF301 / placebo.
- Resultado clínico al final del tratamiento antibacteriano de referencia (EOT), y en la prueba de curación (TOC), y 28 días después de EOT.
- Respuesta microbiológica.
- Resultados microbiológicos. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Clinical outcome: at Day 7 after CF-301/placebo administration, end of standard of care antibacterial therapy (EOT), at test of cure, 28 days after end of standard of care therapy.
- Microbiological response: at Days 7 and 14 after CF-301/placebo administration.
- Microbiological outcome at End of therapy and Test of cure (28 days after end of therapy). |
- Resultado clínico: al día 7 después de la administración de CF-301 /placebo, fin del tratamiento antibacteriano de referencia (EOT), en la prueba de curación, 28 días después del fin del tratamiento de referencia.
- Respuesta microbiológica: los Días 7 y 14 después de la administración de CF-301 / placebo.
- Resultado microbiológico al final del tratamiento y prueba de curación (28 días después del final del tratamiento). |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Belgium |
Bulgaria |
Chile |
Czech Republic |
France |
Germany |
Greece |
Guatemala |
Israel |
Italy |
Russian Federation |
Spain |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |