Clinical trial • Phase IV • Infectious Disease
Amoxicillin sodium for Uncomplicated enterococcal bacteremia
Phase IV trial of Amoxicillin sodium for Uncomplicated enterococcal bacteremia.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Uncomplicated enterococcal bacteremia
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 26-04-2024
- First CTIS Authorization Date
- 29-04-2024
Trial design
Randomised, open-label, control arm: long 14-day regimen with appropriate antibiotic treatment. comparator antibiotics listed in the application include ampicillin; daptomycin; amoxicillin; piperacillin-tazobactam (piperacillin and beta-lactamase inhibitor); vancomycin; linezolid; amoxicillin/clavulanic acid. doses/schedules are not specified in the summary (smpcs referenced in documents). Phase IV trial in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control arm: Long 14-day regimen with appropriate antibiotic treatment. Comparator antibiotics listed in the application include Ampicillin; Daptomycin; Amoxicillin; Piperacillin-tazobactam (piperacillin and beta-lactamase inhibitor); Vancomycin; Linezolid; Amoxicillin/clavulanic acid. Doses/schedules are not specified in the summary (SmPCs referenced in documents).
- Target Sample Size
- 284
- Trial Duration For Participant
- 104
Eligibility
Recruits 284 Vulnerable population selected; trial enrols adult patients (18 years or older). Signed informed consent is required. Subject information and informed consent form documents are provided (L1_SIS and ICF adults). No assent or minor-consent procedures are described..
- Pregnancy Exclusion
- Pregnancy and lactation.
- Vulnerable Population
- Vulnerable population selected; trial enrols adult patients (18 years or older). Signed informed consent is required. Subject information and informed consent form documents are provided (L1_SIS and ICF adults). No assent or minor-consent procedures are described.
Inclusion criteria
- {"criterion_text":"- Adult patients (18 years or older) hospitalized with E. faecalis or E. faecium bacteremia."}
- {"criterion_text":"- Negative control blood cultures performed between days 2-3 of treatment after the start of active treatment."}
- {"criterion_text":"- Disappearance of fever (> 37.8ºC) in the first 72 hours."}
- {"criterion_text":"- Signed informed consent"}
Exclusion criteria
- {"criterion_text":"- Polymicrobial bacteremia."}
- {"criterion_text":"- Patients with limited life expectancy in whom only conservative clinical management had been decided."}
- {"criterion_text":"- Hemodynamic instability on day 5-6 after the start of active treatment."}
- {"criterion_text":"- Patients wearing endovascular devices or heart valves prosthetics."}
- {"criterion_text":"- Outbreak of uncontrolled bacteremia adequately defined as abscess not drained, bile duct infection associated with plastic prostheses not removed or not replaced within the first 72 hours of bacteremia, other infections related to unremoved prostheses, prostatitis, and endocarditis infectious, as well as infections that require prolonged treatment, such as joint and bone infections."}
- {"criterion_text":"- Existence of a secondary focus, different from the initial focus or presence of metastatic focus of infection."}
- {"criterion_text":"- Severe neutropenia (<500 cells / mm3) at the time of diagnosis of bacteremia"}
- {"criterion_text":"- Pregnancy and lactation."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Clinical success at TOC in the ITTP.","definition_or_measurement_approach":"Clinical success measured at Test Of Cure (TOC) in the intention-to-treat population (ITTP) as stated in the trial endpoints."}
Secondary endpoints
- {"endpoint_text":"- Rates of diagnosis of relapse or infective endocarditis in OCD and follow-up visit in the clinically evaluable population (CEP).","definition_or_measurement_approach":"Rates of relapse or infective endocarditis assessed at TOC and follow-up visit in the clinically evaluable population (CEP)."}
- {"endpoint_text":"- Survival in OCD and follow-up visit.","definition_or_measurement_approach":"Survival assessed at TOC and follow-up visit."}
- {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":"Measured as duration of hospital stay (days)."}
- {"endpoint_text":"- Duration of IV and total therapy in CEP","definition_or_measurement_approach":"Measured duration of intravenous therapy and total therapy in the clinically evaluable population (CEP)."}
- {"endpoint_text":"- Infection with C. difficile.","definition_or_measurement_approach":"Occurrence of C. difficile infection during study observation."}
- {"endpoint_text":"- Adverse events and severity","definition_or_measurement_approach":"Recording and grading of adverse events and their severity from informed consent signing until 90 days after administration of study drugs."}
- {"endpoint_text":"- Secondary infections","definition_or_measurement_approach":"Incidence of secondary infections during study observation."}
- {"endpoint_text":"- Change in SOFA score in OCD and follow-up visit.","definition_or_measurement_approach":"Change in Sequential Organ Failure Assessment (SOFA) score measured at TOC and follow-up visit."}
Recruitment
- Planned Sample Size
- 284
- Recruitment Window Months
- 38
- Consent Approach
- Signed informed consent is required from participants. Adult-specific informed consent form is provided (documents: L1_SIS and ICF adults). No assent or minor/parental consent procedures are described. Participant information and ICF translations exist (Spanish translations present).
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 284
Spain
- Earliest CTIS Part Ii Submission Date
- 25-09-2023
- Latest Decision Or Authorization Date
- 08-08-2025
- Processing Time Days
- 683
- Number Of Sites
- 24
- Number Of Participants
- 284
Sites
- Site Name
- Hospital Universitario Torrecardenas
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Maria de los Angeles Esteban Moreno
- Principal Investigator Email
- mariaa.esteban.moreno.sspa@juntadeandalucia.es
- Contact Person Name
- Maria de los Angeles Esteban Moreno
- Contact Person Email
- mariaa.esteban.moreno.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario De Puerto Real
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Alberto Romero Palacios
- Principal Investigator Email
- alberpalacios@hotmail.com
- Contact Person Name
- Alberto Romero Palacios
- Contact Person Email
- alberpalacios@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- María Paniagua García
- Principal Investigator Email
- maria.paniagua89@gmail.com
- Contact Person Name
- María Paniagua García
- Contact Person Email
- maria.paniagua89@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- José María Aguado García
- Principal Investigator Email
- jaguadog1@gmail.com
- Contact Person Name
- José María Aguado García
- Contact Person Email
- jaguadog1@gmail.com
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Pedro María Martínez Pérez-Crespo
- Principal Investigator Email
- pedrompc88@gmail.com
- Contact Person Name
- Pedro María Martínez Pérez-Crespo
- Contact Person Email
- pedrompc88@gmail.com
- Site Name
- Hospital Costa Del Sol
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Alfonso del Arco Jiménez
- Principal Investigator Email
- alfarco@gmail.com
- Contact Person Name
- Alfonso del Arco Jiménez
- Contact Person Email
- alfarco@gmail.com
- Site Name
- Hospital Del Mar
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Silvia Castañeda Espinosa
- Principal Investigator Email
- s.castaneda@psmar.cat
- Contact Person Name
- Silvia Castañeda Espinosa
- Contact Person Email
- s.castaneda@psmar.cat
- Site Name
- Complexo Hospitalario Universitario De Vigo
- Department Name
- UCG Medicina Interna
- Principal Investigator Name
- Rebecca Longueira Suárez
- Principal Investigator Email
- rebeca.longueira@hotmail.com
- Contact Person Name
- Rebecca Longueira Suárez
- Contact Person Email
- rebeca.longueira@hotmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Maria del Carmen Fariñas Álvarez
- Principal Investigator Email
- mcarmen.farinas@scsalud.es
- Contact Person Name
- Maria del Carmen Fariñas Álvarez
- Contact Person Email
- mcarmen.farinas@scsalud.es
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Ignacio de los Santos Gil
- Principal Investigator Email
- isantosg@hotmail.com
- Contact Person Name
- Ignacio de los Santos Gil
- Contact Person Email
- isantosg@hotmail.com
- Site Name
- Hospital Universitario Juan Ramon Jimenez
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Francisco Javier Martínez Marcos
- Principal Investigator Email
- fcojmtz@telefonica.net
- Contact Person Name
- Francisco Javier Martínez Marcos
- Contact Person Email
- fcojmtz@telefonica.net
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Salvador López Cárdenas
- Principal Investigator Email
- salvador_lopez_cardenas@jerez.es
- Contact Person Name
- Salvador López Cárdenas
- Contact Person Email
- salvador_lopez_cardenas@jerez.es
- Site Name
- Hospital Universitario De Jaen
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Maria del Carmen Herrero Rodríguez
- Principal Investigator Email
- gonees.data@hotmail.es
- Contact Person Name
- Maria del Carmen Herrero Rodríguez
- Contact Person Email
- gonees.data@hotmail.es
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Miguel Ángel López Ruz
- Principal Investigator Email
- malruz@ugr.es
- Contact Person Name
- Miguel Ángel López Ruz
- Contact Person Email
- malruz@ugr.es
- Site Name
- Hospital Universitari Mutua Terrassa
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Laura Marina Gisbert Pérez
- Principal Investigator Email
- xxx@mutuaterrassa.cat
- Contact Person Name
- Laura Marina Gisbert Pérez
- Contact Person Email
- xxx@mutuaterrassa.cat
- Site Name
- University Hospital Son Espases
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Helem Haydee Vilchez Rueda
- Principal Investigator Email
- helemh.vilchez@ssib.es
- Contact Person Name
- Helem Haydee Vilchez Rueda
- Contact Person Email
- helemh.vilchez@ssib.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Luis Eduardo López Cortés
- Principal Investigator Email
- luiselopezcortes@gmail.com
- Contact Person Name
- Luis Eduardo López Cortés
- Contact Person Email
- luiselopezcortes@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Encarnación Moral Escudero
- Principal Investigator Email
- emoralescudero@hotmail.com
- Contact Person Name
- Encarnación Moral Escudero
- Contact Person Email
- emoralescudero@hotmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Antonio Plata Ciezar
- Principal Investigator Email
- antonio-plata@hotmail.com
- Contact Person Name
- Antonio Plata Ciezar
- Contact Person Email
- antonio-plata@hotmail.com
- Site Name
- Hospital Universitario Donostia
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Maialen Ibarguren Pinilla
- Principal Investigator Email
- MAIALEN.IBARGURENPINILLA@osakidetza.eus
- Contact Person Name
- Maialen Ibarguren Pinilla
- Contact Person Email
- MAIALEN.IBARGURENPINILLA@osakidetza.eus
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Joaquín López-Contreras González
- Principal Investigator Email
- jlcontreras@santpau.cat
- Contact Person Name
- Joaquín López-Contreras González
- Contact Person Email
- jlcontreras@santpau.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Francesca Gioia Gioia
- Principal Investigator Email
- francesca_gioia@hotmail.com
- Contact Person Name
- Francesca Gioia Gioia
- Contact Person Email
- francesca_gioia@hotmail.com
- Site Name
- Hospital Universitario De Cruces
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Ane Josune Goikoetxea Agirre
- Principal Investigator Email
- ANEJOSUNE.GOIKOETXEAAGIRRE@osakidetza.eus
- Contact Person Name
- Ane Josune Goikoetxea Agirre
- Contact Person Email
- ANEJOSUNE.GOIKOETXEAAGIRRE@osakidetza.eus
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva
- Principal Investigator Name
- Lucía Ramos Merino
- Principal Investigator Email
- merinoluc@gmail.com
- Contact Person Name
- Lucía Ramos Merino
- Contact Person Email
- merinoluc@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- AMOXICILLIN
- Active Substance
- Amoxicillin sodium
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 3 g (maxDailyDoseAmount: 3 g)
- Investigational Product Name
- PIPERACILLIN AND BETA-LACTAMASE INHIBITOR (piperacillin-tazobactam)
- Active Substance
- Piperacillin sodium; Tazobactam sodium
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 12 g (maxDailyDoseAmount: 12 g)
- Investigational Product Name
- VANCOMYCIN
- Active Substance
- Vancomycin
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 30 mg/kg (maxDailyDoseAmount: 30 mg/kg)
- Investigational Product Name
- DAPTOMYCIN
- Active Substance
- Daptomycin
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 10 mg/kg (maxDailyDoseAmount: 10 mg/kg)
- Investigational Product Name
- Amoxicilina/Ácido clavulánico Sandoz 1.000 mg/200 mg (amoxicillin/clavulanic acid)
- Active Substance
- Amoxicillin sodium; Clavulanic acid
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 3 g (maxDailyDoseAmount: 3 g)
- Investigational Product Name
- LINEZOLID (oral and IV formulations listed)
- Active Substance
- Linezolid
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE / INTRAVENOUS USE
- Route
- ORAL / INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 600 mg (common listed maxDailyDoseAmount for oral product: 600 mg; IV forms list up to 1200 mg in some entries)
- Investigational Product Name
- AMPICILLIN
- Active Substance
- Ampicillin sodium
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 8 g (maxDailyDoseAmount: 8 g)
- Combination Treatment
- Yes
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