E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa |
Prevención de la neumonía nosocomial causada por Pseudomonas aeruginosa |
|
E.1.1.1 | Medical condition in easily understood language |
Prevention of Pseudomonas aeruginosa pneumonia occurring in the hospital |
Prevención de la neumonía nosocomial por Pseudomonas aeruginosa que ocurren en el hospital |
|
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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051190 |
E.1.2 | Term | Pneumonia Pseudomonas aeruginosa |
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 |
1. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa 2. To evaluate the safety of a single IV dose of MEDI3902 in mechanically ventilated patients |
1. Evaluar el efecto de MEDI3902 sobre la reducción de la incidencia de neumonía nosocomial causada por P aeruginosa. 2. Evaluar la seguridad de una dosis IV única de MEDI3902 en pacientes sometidos a ventilación mecánica. |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the serum pharmacokinetics (PK) of MEDI3902 2. To evaluate the serum anti-drug antibody (ADA) responses to MEDI3902 3. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa by mechanical ventilation status |
1. Evaluar la farmacocinética (FC) en suero de MEDI3902. 2. Evaluar las respuestas de anticuerpos contra el fármaco (ACF) en suero frente a MEDI3902. 3. Evaluar el efecto de MEDI3902 sobre la reducción de la incidencia de neumonía nosocomial causada por P aeruginosa por estado de ventilación mecánica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Colonized with Pseudomonas aeruginosa in respiratory tract, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. |
Colonización por Pseudomonas aeruginosa en el tracto respiratorio, se espera requerir intubación y ventilación mecánica prolongada, sin ninguna evidencia de neumonía activa. |
|
E.4 | Principal exclusion criteria |
Pseudomonas disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving anti-pseudomonas antibiotics; moribund patients. |
Enfermedad por pseudomonas en el momento de la aleatorización; lesión pulmonar con una puntuación consistente con neumonía; Enfermedad pulmonar actual; actualmente recibiendo antibióticos contra pseudomonas; pacientes moribundos. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Incidence of nosocomial pneumonia caused by P aeruginosa
- Treatment emergent adverse events (TEAEs) treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs) through 49 days postdose |
- Incidencia de neumonía nosocomial provocada por Pseudomonas aeruginosa
- Acontecimiento Adverso de aparición durante el tratamiento (AAAT), Acontecimiento Adverso Grave de aparición durante el tratamiento (AAGAT), Acontecimiento Adverso de interes especial (AAIE) y enfermedades crónicas de nueva aparición (ECNA) hasta 49 días después de la dosis. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Through 49 days postdose |
Hasta 49 días después de la dosis. |
|
E.5.2 | Secondary end point(s) |
1. MEDI3902 serum concentration and PK parameters 2. MEDI3902 ADA response in serum 3. Incidence of nosocomial pneumonia caused by P aeruginosa while on mechanical ventilation 4. Incidence of nosocomial pneumonia caused by P aeruginosa after mechanical ventilation is no longer required |
1. Concentración sérica y parámetros FC de MEDI3902 2. Respuesta de ACF frente a MEDI3902 en suero 3. Incidencia de neumonía nosocomial provocada por P aeruginosa mientras está sometido a ventilación mecánica 4. Incidencia de neumonía nosocomial provocada por P aeruginosa después de la retirada de la ventilación mecánica |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Through 49 days postdose |
Hasta 49 días después de la dosis. |
|
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 | 120 |
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 |
Austria |
Belgium |
Bulgaria |
Croatia |
Czech Republic |
France |
Germany |
Greece |
Hungary |
Israel |
Portugal |
Romania |
Spain |
Switzerland |
Turkey |
United Kingdom |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |