E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Staphyloccus aureus pneumonia |
Prevención de neumonía por Staphylococcus aureus |
|
E.1.1.1 | Medical condition in easily understood language |
Staphyloccus aureus pneumonia |
Neumonía por Staphylococcus aureus |
|
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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041942 |
E.1.2 | Term | Staphylococcus aureus pneumonia |
E.1.2 | System Organ Class | 100000004862 |
|
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 evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia * To evaluate the safety of a single IV dose of MEDI4893 |
* Evaluar el efecto de MEDI4893 sobre la reducción de la incidencia de neumonía por S. aureus. * Evaluar la seguridad de una dosis IV única de MEDI4893. |
|
E.2.2 | Secondary objectives of the trial |
* To evaluate the serum pharmacokinetics (PK) of MEDI4893 * To evaluate the serum anti-drug antibody (ADA) responses to MEDI4893 * To evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia by mechanical ventilation status |
* Evaluar la farmacocinética (FC) en suero de MEDI4893. * Evaluar las respuestas de anticuerpos contra el fármaco (ACF) en suero frente a MEDI4893. * Evaluar el efecto de MEDI4893 sobre la reducción de la incidencia de neumonía por S. aureus según el estado de ventilación mecánica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Colonized with S aureus , expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. |
Colonizados por S aureus, se espera requerir intubación y ventilación mecánica prolongada, sin ninguna evidencia de neumonía activa. |
|
E.4 | Principal exclusion criteria |
Staphylococcal disease at randomisation; lung injury score consistent with pneumonia; current lung disease; chronic tracheostomy patients; currently receiving systemic anti-staphylococcal antibiotics; moribund patients. |
Enfermedad estafilocócica en el momento de la aleatorización; lesión pulmonar con una puntuación consistente con neumonía; enfermedad pulmonar actual; pacientes crónicos de traqueotomía; actualmente recibiendo antibióticos sistémicos contra estafilococo; pacientes moribundos. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Incidence of S aureus pneumonia
2. Safety of MEDI4893 |
1. Incidencia de neumonía por S. aureus
2. Seguridad de MEDI4893 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 30 Days post dose
2. TEAEs through 30 days and 90 days post dose, TESAEs, AESIs, NOCDs through 360 days post dose. |
1. 30 días después de la dosis.
2. Acontecimientos adversos de aparición durante el tratamiento (AAAT) hasta 30 y 90 días después de la dosis, Acontecimientos adversos graves de aparición durante el tratamiento (AAGAT), acontecimientos adversos de interés especial (AAIE) y enfermedades crónicas de nueva aparición (ECNA) hasta 360 días después de la dosis. |
|
E.5.2 | Secondary end point(s) |
* MEDI4893 serum PK * MEDI4893 ADA response in serum * Incidence of S aureus pneumonia on mechanical ventilation * Incidence of S aureus pneumonia after extubation |
* FC de MEDI4893 en suero. * Respuesta de ACF frente a MEDI4893 en suero. * Incidencia de neumonía por S. aureus durante la ventilación mecánica. * Incidencia de neumonía por S. aureus después de la ventilación mecánica. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
* Serum PK and ADA: 90 days * S aureus pneumonia: 30 days |
* FC en suero y ACF: 90 días * Neumonía por S. aureus: 30 días |
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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 | Yes |
E.6.3 | Therapy | No |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | 3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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 |
|
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
|
End of trial is last subject last visit. |
Se define el fin de ensayo como la 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |