Clinical trial • Infectious Disease
Clinical trial in Severe Gram-negative bacterial infections | Gram-negative bacteremia | Pneumonia due to other gram-negative bacteria
Clinical trial for Severe Gram-negative bacterial infections | Gram-negative bacteremia | Pneumonia due to other gram-negative bacteria. 1200 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Severe Gram-negative bacterial infections | Gram-negative bacteremia | Pneumonia due to other gram-negative bacteria
Key dates
- Initial CTIS Submission Date
- 02-06-2025
- First CTIS Authorization Date
- 09-09-2025
Trial design
Clinical trial across 21 sites in Spain.
- Target Sample Size
- 1200
Eligibility
Recruits 1200 No vulnerable populations selected (isVulnerablePopulationSelected: false); no additional information on consent/assent handling provided..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false); no additional information on consent/assent handling provided.
Recruitment
- Planned Sample Size
- 1200
- Recruitment Window Months
- 18
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 1200
Spain
- Earliest CTIS Part Ii Submission Date
- 11-08-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 182
- Number Of Sites
- 21
- Number Of Participants
- 1200
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Carmen Fariñas Álvarez
- Principal Investigator Email
- mcarmen.farinas@scsalud.es
- Contact Person Name
- Carmen Fariñas Álvarez
- Contact Person Email
- mcarmen.farinas@scsalud.es
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Miguel Ángel López Zúñiga
- Principal Investigator Email
- miguelangellopezzuniga@gmail.com
- Contact Person Name
- Miguel Ángel López Zúñiga
- Contact Person Email
- miguelangellopezzuniga@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Servicio de Infecciosas y Medicina Interna
- Principal Investigator Name
- Beatriz Díaz Pollán
- Principal Investigator Email
- bdiazp@salud.madrid.org
- Contact Person Name
- Beatriz Díaz Pollán
- Contact Person Email
- bdiazp@salud.madrid.org
- Site Name
- Bellvitge University Hospital
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Oscar Murillo Rubio
- Principal Investigator Email
- omurillo@bellvitgehospital.cat
- Contact Person Name
- Oscar Murillo Rubio
- Contact Person Email
- omurillo@bellvitgehospital.cat
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Servicio de Enfermedades Infecciosas y Medicina Interna.
- Principal Investigator Name
- Carmen Sáez Béjar
- Principal Investigator Email
- carmenmaria.saez@salud.madrid.org
- Contact Person Name
- Carmen Sáez Béjar
- Contact Person Email
- carmenmaria.saez@salud.madrid.org
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Esperanza Merino de Lucas
- Principal Investigator Email
- merino_luc@gva.es
- Contact Person Name
- Esperanza Merino de Lucas
- Contact Person Email
- merino_luc@gva.es
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- UGC Enfermedades Infecciosas y Microbiología
- Principal Investigator Name
- Nicolás Merchante Gutierrez
- Principal Investigator Email
- nicolasmerchante@gmail.com
- Contact Person Name
- Nicolás Merchante Gutierrez
- Contact Person Email
- nicolasmerchante@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Isabel A. Pérez Hernández
- Principal Investigator Email
- isaperezhernandez@gmail.com
- Contact Person Name
- Isabel A. Pérez Hernández
- Contact Person Email
- isaperezhernandez@gmail.com
- Site Name
- Hospital Virgen del Rocio
- Department Name
- UGC Enfermedades Infecciosas
- Principal Investigator Name
- José Molina Gil Bermejo
- Principal Investigator Email
- josemolinagb@gmail.com
- Contact Person Name
- José Molina Gil Bermejo
- Contact Person Email
- josemolinagb@gmail.com
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Josune Goikoetxea Agirre
- Principal Investigator Email
- anejosune.goikoetxeaagirre@osakidetza.eus
- Contact Person Name
- Josune Goikoetxea Agirre
- Contact Person Email
- anejosune.goikoetxeaagirre@osakidetza.eus
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Servicio de Enfermedades Infecciosas y Microbiología
- Principal Investigator Name
- Jesús Rodríguez Baño
- Principal Investigator Email
- jesusrb@us.es
- Contact Person Name
- Jesús Rodríguez Baño
- Contact Person Email
- jesusrb@us.es
- Site Name
- Hospital Regional Universitario de Málaga
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Antonio Plata Ciézar
- Principal Investigator Email
- antonio-plata@hotmail.com
- Contact Person Name
- Antonio Plata Ciézar
- Contact Person Email
- antonio-plata@hotmail.com
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Emilio Guirao Arrabal
- Principal Investigator Email
- emilio.guirao@gmail.com
- Contact Person Name
- Emilio Guirao Arrabal
- Contact Person Email
- emilio.guirao@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Servicio de Microbiología
- Principal Investigator Name
- Laura López González
- Principal Investigator Email
- miguel.sanchez@salud.madrid.org
- Contact Person Name
- Laura López González
- Contact Person Email
- miguel.sanchez@salud.madrid.org
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- José Ramón Paño Pardo
- Principal Investigator Email
- jrpanno@unizar.es
- Contact Person Name
- José Ramón Paño Pardo
- Contact Person Email
- jrpanno@unizar.es
- Site Name
- Hospital Del Mar
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Juan Pablo Horcajada Gallego
- Principal Investigator Email
- jhorcajada@hmar.cat
- Contact Person Name
- Juan Pablo Horcajada Gallego
- Contact Person Email
- jhorcajada@hmar.cat
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Unidad de Patología Infecciosa (Servicio de Enfermedades Infecciosas)
- Principal Investigator Name
- Francisco Félix Rodríguez Vidigal
- Principal Investigator Email
- franciscof.rodriguez@salud-juntaex.es
- Contact Person Name
- Francisco Félix Rodríguez Vidigal
- Contact Person Email
- franciscof.rodriguez@salud-juntaex.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio de Microbiología Clínica y Enfermedades Infecciosas
- Principal Investigator Name
- Patricia Muñóz García
- Principal Investigator Email
- patricia.munoz.garcia@salud.madrid.org
- Contact Person Name
- Patricia Muñóz García
- Contact Person Email
- patricia.munoz.garcia@salud.madrid.org
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Servicio de Medicina Interna. Unidad de Enfermedades Infecciosas
- Principal Investigator Name
- María Teresa Pérez-Rodríguez
- Principal Investigator Email
- perezrodriguezmt@gmail.com
- Contact Person Name
- María Teresa Pérez-Rodríguez
- Contact Person Email
- perezrodriguezmt@gmail.com
- Site Name
- Hospital Universitario Donostia
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Francisco de Asis Carmona de la Torre
- Principal Investigator Email
- FRANCISCODEASIS.CARMONADELATORRE@osakidetza.eus
- Contact Person Name
- Francisco de Asis Carmona de la Torre
- Contact Person Email
- FRANCISCODEASIS.CARMONADELATORRE@osakidetza.eus
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Isabel M. Machuca Sánchez
- Principal Investigator Email
- isabelm.machuca.sspa@juntadeandalucia.es
- Contact Person Name
- Isabel M. Machuca Sánchez
- Contact Person Email
- isabelm.machuca.sspa@juntadeandalucia.es
Sponsor
Primary sponsor
- Full Name
- Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
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