| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| SUSPECTED OR PROVEN LATE ONSET NEONATAL SEPSIS |
| Sepsis de inicio tardío en niños menores de 90 días |
|
| E.1.1.1 | Medical condition in easily understood language |
| SEPSIS IN NEONATOS AND YOUNG INFANTS |
| Infecciones tardías en niños menores de 90 días |
|
| 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 | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10053840 |
| E.1.2 | Term | Bacterial sepsis |
| 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 compare the efficacy at TOC visit of meropenem to the standard of care in the treatment of clinical or confirmed LOS in infants < or = 90 days of postnatal age |
| Comparar la eficacia del meropenem con el tratamiento estándar en la sepsis de inicio tardío clínica o confirmada en niños menores de 90 días. |
|
| E.2.2 | Secondary objectives of the trial |
- To compare the sfaety profile of meropenem to SOC.
- To compare the fficacy of meropenem to SOC in confirmed sepsis.
- To compare the response to meropenem and SOC.
- To compare the efficacy at TOC visit of meropenem to SOC by SOC regimen.
- To compare survival at Day 28 in meropenem and SOC arms.
- To evaluate new infections and relapses.
- To define the organisms causing LOS.
- To atudy antibacterial susceptibility of LOS-causing organisms and to describe clinical and microbiologocal responses according to this.
- To compare gut colonization by resistant organisms.
- To compare bacterial eradication by tratment arm.
- To compare time to NICU discharge.
- To describe PK of meropenem in infants < or = 90 days of postnatal age with LOS
- To evaluate genetic parameters that may affect response to therapy. |
Comparar el perfil de seguridad de meropenem frente a SOC
Comparar la eficacia de meropenem con la del SOC en casos de sepsis confirmada
Comparar la respuesta a meropenem y al SOC
Comparar la eficacia de meropenem frente al SOC en la visita TOC según el régimen del SOC
Comparar la supervivencia en el día 28 de meropenem frente al SOC
Comparar nuevas infecciones y recaídas Definir los organismos que causan la sepsis neonatal tardía
Estudiar la susceptibilidad antibacteriana de los organismos causantes de LOS y describir las respuestas clínicas y microbiológicas según esto
Comparar la colonización intestinal por organismos resistentes
Comparar la erradicación bacteriana en un grupo de tratamiento frente al otro
Comparar el período hasta obtención del alta de UCIN
Describir la FC (farmacocinética) de meropenem en niños de ? 90 días de edad postnatal con LOS
Evaluar los parámetros genéticos que pueden afectar a la respuesta al tratamiento |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
- Pharmacokinetics of meropenem in neonatos infants < =90 days of postnatal age with LOS. 11.05.2001 / version 1.0
- Microbiology substudy. 11.05.2001 / version 1.0
- Genetic determinants of susceptibility to sepsis and to differential responses to Meropenem. 11.05.2001 / version 1.0 |
Farmacocinética de meropenem en neonatos menores de 90 días de edad postnatal con sepsis de inicio tardío. 11-05-2011. Version 1.0
Subestudio microbiológico. 11-05-2011. Versión 1.0
Determinantes genéticos de susceptibilidad a sepsis y a respuesta diferencial a meropenem. 11-05-2011. Version 1.0 |
|
| E.3 | Principal inclusion criteria |
- Inform consent form signed by parents/carers.
- Chronological age below 90 days inclusive.
- Chronological age greater or equal to 72 hours of life at beginning of LOS
- Clinical or confirmed sepsis. |
-Consentimiento informado firmado por los padres/tutores
- Edad de hasta 90 días, inclusive
- Edad de al menos 72 horas al inicio de la LOS
- Sepsis clínica o confirmada |
|
| E.4 | Principal exclusion criteria |
- Administration of any systemic antibiotic regimn for more than 24 hours prior to the administration of the study drug, unless the change is driven by the lack of efficacy of the former regimen;
- Severe congenital malformations in the infant is not expected to survive for more than 3 months;
- Other situations where the treating pysician considers a different antibiotic regimen necessary;
- Known intolerance or contraindication to study medication;
- Participation in any other clinical study of investigational drugs;
- Renal failure (as defined by Akcan-ARikan et al., 2007) and requirement for haemofiltration or peritoneal dialysis;
- Confirmed sepsis with micororganisms known to be resistant to study therapies |
- Administración de tratamiento antibiótico en las 24 horas previas al inicio de la administración del antibiótico de estudio;
- Malformaciones congénitas severas con supervivencia menor a 3 meses;
- Intolerancia o contraindicación de la medicación de estudio;
- Participación en otro estudio de administración de medicación
- Fallo renal o diálisis peritoneal o hemofiltro;
- Sepsis confirmada por un microorganismos resistente a la medicación de estudio |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Favourable outcome at the TOC (Test of Cure) visit performed 2 days after COT (Completion of Therapy), defined as an infant alive, with resolution or significant improvement of all abnormalities that defined LOS, with microbiological eradication and no change in the treatment allocated at randomisation. |
| Resultado favorable del tratamiento a los 2 días después de finalizar el mismo, definido como paciente vivo, con resolución o mejoría de las alteraciones por las que se definieron la sepsis de inicio tardío, con erradicación microbiológica y no cambios en el tratamiento. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| TOC (Test of Cure) visit is performed 2 days after COT (Completiion of 11 +/- 3 days of Antibiotic Therapy) |
| A los 2 días de finalizar el tratamiento (11+/- 3 días) |
|
| E.5.2 | Secondary end point(s) |
- Description of all clinical and biological adverse events experienced by infants receiving meropenem or comparator agents.
- Clinical and biological response in all patients and also in patients with positive baseline cultures at Day 3, at COT, at EOT (End of Therapy) and EOAT (End of Allocated Treatment).
- Survival at Day 28.
- New infections or relapses of LOS that occur between TOC and FU visit in participants with a favourable outcome at TOC visit. |
Descripción de todos los eventos adversos clínicos y biológicos experimentados durante la administración de meropenem o tratamiento comparador.
Supervivencia a los 28 días.
Nuevas infecciones o recaídas |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| End of allocated treatment (EOAT) - the point in time when allocated therapy for LOS is stopped, that means the last day of allocated treatment. If EOAT is within 11 ± 3 days and no other antibiotic is continued, EOAT = COAT End of treatment (EOT) signifies the point in time when antibiotic therapy for LOS is stopped. If EOT is within 11 ± 3 days, EOT = COT. If there is no change of allocated therapy COT = COAT. FU (follow up) visit is performed at Day 28 ± 3 |
| Durante el tratamiento y hasta la finalización del seguimiento |
|
| 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 | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Yes |
| 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) | Yes |
| 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 | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| 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
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 24 |
| 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 | 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
|
| IDMC performs an interim review of the trial's progress including updated figures on recruitment, data quality, and main safety and efficacy outcomes. Based on its review, the IDMC will provide within 15 days after each of its meetings a brief formal written report with recommendations to the sponsor regarding study modification, continuation or termination. |
| IDMC realiza un análisis provisional de los avances del ensayo, incluyendo las cifras actualizadas sobre el reclutamiento, la calidad de datos y de seguridad principal y los resultados de eficacia. Basándose en su examen, el IDMC proporcionará dentro de los 15 días después de cada una de sus reuniones un breve informe formal por escrito con recomendaciones para el patrocinador respecto de la modificación del estudio, la continuación o terminación |
|
| 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 | 1 |
| 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 | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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