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Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins (ASTARTÉ)

Primary Purpose

Bacteremia

Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Temocillin
Meropenem
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteremia focused on measuring Bacteraemia, Enterobacteriaceae, Temocillin, Third-generation cephalosporin-resistant Enterobacteriaceae.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with monomicrobial bacteraemia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC >2 mg/L) and/or ceftazidime (MIC >4 mg/L), ands sensible to temocillin (MIC ≤8 mg/L) and meropenem (MIC ≤2 mg/L).
  • Duration of intravenous treatment is planned to be at least 4 days.
  • The patient signed informed consent form.

Exclusion Criteria:

  • <18 years
  • Pregnancy
  • Breastfeeding
  • Palliative care
  • Allergy to betalactams
  • Polymicrobial bacteraemia
  • Meningitis
  • Infections typically needing prolonged >14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis)
  • Severe neutropenia
  • Shock
  • Active empirical treatment> 96 hours after initial blood culture extraction

Sites / Locations

  • Hospital Clínico Universitario de Santiago
  • Hospital ParcTaulíRecruiting
  • Hospital Universitario Mútua TerrassaRecruiting
  • Hospital Universitario de Cruces
  • Hospital Marqués de ValdecillaRecruiting
  • Hospital Universitario de Jerez de la FronteraRecruiting
  • Hospital Universitario de Puerto RealRecruiting
  • Complejo Hospitalario San Millán-San Pedro De La RiojaRecruiting
  • Complejo Hospitalario de NavarraRecruiting
  • Complejo Hospitalario Universitario La CoruñaRecruiting
  • Hospital General Universitario de AlicanteRecruiting
  • Hospital Universitario TorrecárdenasRecruiting
  • Hospital del MarRecruiting
  • Hospital Clínic de Barcelona
  • Hospital Sant PauRecruiting
  • Hospital Universitario Reina SofíaRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Universitario Clínico San CecilioRecruiting
  • Hospital Universitario Juan Ramón JiménezRecruiting
  • Complejo Hospitalario de Jaén
  • Hospital Universitario Locus Augusti, LugoRecruiting
  • Hospital Universitario de la PrincesaRecruiting
  • Hospital General Universitario Gregorio MarañónRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario La Paz
  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
  • Hospital Regional de MálagaRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital Universitari Son EspasesRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Universitario Virgen de ValmeRecruiting
  • Complejo Hospitalario Universitario de VigoRecruiting
  • Hospital Clínico Universitario Lozano Blesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Temocillin

Meropenem

Arm Description

Patients enrolled in this arm, will receive 2g each 8 hours of intravenous temocillin.

Patients enrolled in this arm, will receive 1g each 8 hours of intravenous meropenem.

Outcomes

Primary Outcome Measures

Number of participants with a "success" at the test of cure (TOC)
A success at the test of cure is the resolution of infection symptoms
Survival at day 28
Number of patients who are alive
Number of patients who do not need to stop or change the assigned drug
Reasons for not change can be no adverse event, no perceived failure during treatment or no occurrence of a superimposed infection. Participants who stop or change the assigned drug will not meet the primary outcome.
Number of patients who do not need to prolong therapy beyond 14 days
Assigned treatment to be administered for less than 14 days
Not recurrence until day 28
Recurrence is reappearance of symptoms with positive blood culture for the same microorganism. Participants with recurrence will not meet the primary outcome.

Secondary Outcome Measures

28-day mortality
Number of patients dead up to day 28.
Length of hospital stay (days)
Number of days patients has been in-hospital
Length of intravenous therapy (days)
Number of days patients has been under intravenous antibiotic treatment
Length of total administration of therapy (days)
Number of days patients has been under intravenous or oral antibiotic treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of subjects with resistance development during therapy
Resistance development will be measured in a positive blood culture
Recurrence rate
Percentage of subjects with recurrence
Changes in Sequential Organ failure (SOFA) score
Sequential Organ failure (SOFA) score changes
Changes in Barthel Index for Activities of Daily Living (ADL) for patients older than 70 years old
Barthel Index for Activities of Daily Living (ADL) score changes; score from 0, completely dependent patient to 100, completely independent for activities of daily living

Full Information

First Posted
March 23, 2020
Last Updated
May 2, 2023
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Spanish Network for Research in Infectious Diseases, SCReN Spanish research Network- CTU-HUVR
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1. Study Identification

Unique Protocol Identification Number
NCT04478721
Brief Title
Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins
Acronym
ASTARTÉ
Official Title
Randomised Controlled Trial of Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Due to Enterobacteriaceae Showing Resistance to Third Generation Cephalosporins
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Spanish Network for Research in Infectious Diseases, SCReN Spanish research Network- CTU-HUVR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae. The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
Detailed Description
The objective of the trial is to demonstrate the non-inferiority of temocillin (2g each 8 hours, intravenous) to carbapenems (meropenem 1g each 8 hours, intravenous) in terms of efficacy and safety in the targeted treatment of bacteraemia due to Enterobacteriaceae resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections. The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
Keywords
Bacteraemia, Enterobacteriaceae, Temocillin, Third-generation cephalosporin-resistant Enterobacteriaceae.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized 1.1 to temocillin: meropenem
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temocillin
Arm Type
Experimental
Arm Description
Patients enrolled in this arm, will receive 2g each 8 hours of intravenous temocillin.
Arm Title
Meropenem
Arm Type
Active Comparator
Arm Description
Patients enrolled in this arm, will receive 1g each 8 hours of intravenous meropenem.
Intervention Type
Drug
Intervention Name(s)
Temocillin
Intervention Description
The intervention of experimental arm will be Intravenous administration of temocillin.
Intervention Type
Drug
Intervention Name(s)
Meropenem
Intervention Description
The intervention of comparator arm will be intravenous administration of meropenem.
Primary Outcome Measure Information:
Title
Number of participants with a "success" at the test of cure (TOC)
Description
A success at the test of cure is the resolution of infection symptoms
Time Frame
Up to 7-10 days after the last day of antibiotic therapy
Title
Survival at day 28
Description
Number of patients who are alive
Time Frame
At day 28.
Title
Number of patients who do not need to stop or change the assigned drug
Description
Reasons for not change can be no adverse event, no perceived failure during treatment or no occurrence of a superimposed infection. Participants who stop or change the assigned drug will not meet the primary outcome.
Time Frame
Up to 7-14 days after the last day of antibiotic therapy
Title
Number of patients who do not need to prolong therapy beyond 14 days
Description
Assigned treatment to be administered for less than 14 days
Time Frame
Up to 7-14 days after the last day of antibiotic therapy
Title
Not recurrence until day 28
Description
Recurrence is reappearance of symptoms with positive blood culture for the same microorganism. Participants with recurrence will not meet the primary outcome.
Time Frame
At day 28.
Secondary Outcome Measure Information:
Title
28-day mortality
Description
Number of patients dead up to day 28.
Time Frame
Up to day 28.
Title
Length of hospital stay (days)
Description
Number of days patients has been in-hospital
Time Frame
Through study completion, an average of 28 days
Title
Length of intravenous therapy (days)
Description
Number of days patients has been under intravenous antibiotic treatment
Time Frame
From day 1 of intravenous antibiotic treatment administration to last intravenous administration, average 14 days
Title
Length of total administration of therapy (days)
Description
Number of days patients has been under intravenous or oral antibiotic treatment
Time Frame
From day 1 of intravenous or oral antibiotic treatment administration to last intravenous or oral administration, average 14 days
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Up to day 28
Title
Number of subjects with resistance development during therapy
Description
Resistance development will be measured in a positive blood culture
Time Frame
Up to day 28
Title
Recurrence rate
Description
Percentage of subjects with recurrence
Time Frame
Up to day 28.
Title
Changes in Sequential Organ failure (SOFA) score
Description
Sequential Organ failure (SOFA) score changes
Time Frame
At days 1, 3, end of treatment (days 7-14) and visit 4
Title
Changes in Barthel Index for Activities of Daily Living (ADL) for patients older than 70 years old
Description
Barthel Index for Activities of Daily Living (ADL) score changes; score from 0, completely dependent patient to 100, completely independent for activities of daily living
Time Frame
At days 1, 3, end of treatment (days 7-14) and visit 4
Other Pre-specified Outcome Measures:
Title
Peak Plasma Concentration (Cmax) of temocillin
Description
Exploratory objective in a reduced number of patients on which plasma levels of temocillin will be measured to determine maximum plasma levels of temocillin
Time Frame
At 1hour, 4hours, 6hours and y 8hours from temocillin first infusion, on days 1 and 3
Title
Minimum Plasma Concentration (Cmin) of temocillin
Description
Exploratory objective in a reduced number of patients on which plasma levels of temocillin will be measured to determine minimum plasma levels of temocillin
Time Frame
At 1hour, 4hours, 6hours and y 8hours from temocillin first infusion, on days 1 and 3
Title
Area under the plasma concentration versus time curve (AUC) of temocillin
Description
Exploratory objective in a reduced number of patients on which plasma levels of temocillin will be measured to determine area under curve of temocillin
Time Frame
At 1hour, 4hours, 6hours and y 8hours from temocillin first infusion, on days 1 and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with monomicrobial bacteremia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC >2 mg/L) and/or ceftazidime (MIC >4 mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinary origin, for which the criterion is MIC ≤16 mg/L ) and meropenem (MIC ≤2 mg/L). Duration of intravenous treatment is planned to be at least 4 days. The patient signed informed consent form. Exclusion Criteria: <18 years Pregnancy Breastfeeding Palliative care Allergy to betalactams Polymicrobial bacteraemia Infections typically needing prolonged >14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis) or meningitis Active empirical treatment> 96 hours after initial blood culture extraction Delay in inclusion> 48 h Recruited in another clinical trial with active treatment Peritoneal dialysis or continuous hemofiltration extreme gravity or imminent death
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clara Rosso
Phone
+34955013414
Email
claram.rosso@juntadeandalucia.es
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Borreguero
Phone
+34955007609
Email
irene.borreguero@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús Rodriguez Baño
Organizational Affiliation
Hospital Universitario Virgen Macarena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital ParcTaulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oriol Gasch Blasi
Email
ogasch@tauli.cat
First Name & Middle Initial & Last Name & Degree
Oriol Gasch Blasi, Clínico
Facility Name
Hospital Universitario Mútua Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Calbo Sebastián
Email
ecalbo@mutuaterrassa.es
First Name & Middle Initial & Last Name & Degree
Esther Calbo Sebastián, Clínico
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Carmen Fariñas Álvarez
Email
mcfarinas@humv.es
First Name & Middle Initial & Last Name & Degree
M. Carmen Fariñas Álvarez, Clínico
Facility Name
Hospital Universitario de Jerez de la Frontera
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvador López Cárdenas
Email
salvador_lopez_cardenas@jerez.es
First Name & Middle Initial & Last Name & Degree
Salvador López Cárdenas, Clínico
Facility Name
Hospital Universitario de Puerto Real
City
Puerto Real
State/Province
Cádiz
ZIP/Postal Code
11510
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Romero Palacios
Email
alberpalacios@hotmail.com
First Name & Middle Initial & Last Name & Degree
Alberto Romero Palacios, Clínico
Facility Name
Complejo Hospitalario San Millán-San Pedro De La Rioja
City
Autol
State/Province
La Rioja
ZIP/Postal Code
26560
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Antonio Oteo Revuelta
Phone
941298993
Email
jaoteo@riojasalud.es
First Name & Middle Initial & Last Name & Degree
José Antonio Oteo Revuelta, Clínico
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Ramón Yuste Ara
Email
jryuste@unav.es
First Name & Middle Initial & Last Name & Degree
José Ramón Yuste Ara, Clínico
Facility Name
Complejo Hospitalario Universitario La Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores Sousa Regueiro
Email
Dolores.Sousa.Regueiro@sergas.es
First Name & Middle Initial & Last Name & Degree
Dolores Sousa Regueiro, Clínico
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esperanza Merino de Lucas
Email
merinoluc@gmail.com
First Name & Middle Initial & Last Name & Degree
Esperanza Merino de Lucas, Clínico
Facility Name
Hospital Universitario Torrecárdenas
City
Almería
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Ángeles Esteban Moreno
Email
ma.esteban.moreno@gmail.com
First Name & Middle Initial & Last Name & Degree
M. Ángeles Esteban Moreno, Clínico
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Pablo Horcajada Gallego
Phone
932483251
Email
JHorcajada@parcdesalutmar.cat
First Name & Middle Initial & Last Name & Degree
Juan Pablo Horcajada Gallego, Clínico
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquín López-Contreras González López-Contreras González
Email
jlcontreras@santpau.cat
First Name & Middle Initial & Last Name & Degree
Joaquín López-Contreras González, Clínico
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ángela Cano Yuste
Email
cayuam@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ángela Cano Yuste, Clínico
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ángel López
Email
malruz@ugr.es
First Name & Middle Initial & Last Name & Degree
Miguel Ángel López, Clínico
Facility Name
Hospital Universitario Clínico San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés Ruiz Sancho
Email
andresruizsancho@yahoo.es
First Name & Middle Initial & Last Name & Degree
Andrés Ruiz Sancho, Clínico
Facility Name
Hospital Universitario Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Martínez Marcos
Phone
954765204
Email
fcojmtz@telefonica.net
First Name & Middle Initial & Last Name & Degree
Francisco Javier Martínez Marcos, Clínico
Facility Name
Complejo Hospitalario de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Locus Augusti, Lugo
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mª José García País
Email
maria.jose.garcia.pais@sergas.es
First Name & Middle Initial & Last Name & Degree
Mª José García País, Clínico
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Barrios Blandino
Email
abarrios@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Ana Barrios Blandino, Clínico
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Olmedo Samperio
Email
maria.olmedo.samperio@gmail.com
First Name & Middle Initial & Last Name & Degree
María Olmedo Samperio, Clínico
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Escudero
Email
rosaescudero0@gmail.com
First Name & Middle Initial & Last Name & Degree
Rosa Escudero, Clínico
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa García Vázquez, Clinico
Email
elisagarciavazquez@gmail.com
First Name & Middle Initial & Last Name & Degree
Elisa García Vázquez, Clínico
Facility Name
Hospital Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucía Valiente de Santis
Email
luciabvds26@hotmail.com
First Name & Middle Initial & Last Name & Degree
Lucía Valiente de Santis, Clínico
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Nuño Álvarez
Email
enrique.nuno@gmail.com
First Name & Middle Initial & Last Name & Degree
Enrique Nuño Álvarez, Clínico
Facility Name
Hospital Universitari Son Espases
City
Palma
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Peñaranda Vera
Phone
871205371
Email
maria.penaranda@ssib.es
First Name & Middle Initial & Last Name & Degree
María Peñaranda Vera, Clínico
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesús Rodríguez Baño
Email
jesusrb@us.es
First Name & Middle Initial & Last Name & Degree
Jesús Rodríguez Baño, Clínico
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Enrique Jiménez Mejías
Email
mej-mejias@telefonica.net
First Name & Middle Initial & Last Name & Degree
Manuel Enrique Jiménez Mejías, Clínico
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Corzo Delgado
Email
juanecorzo@telefonica.net
First Name & Middle Initial & Last Name & Degree
Juan Corzo Delgado, Clínico
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
ZIP/Postal Code
36313
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Teresa Pérez Rodríguez
Email
perezrodriguezmt@gmail.com
First Name & Middle Initial & Last Name & Degree
María Teresa Pérez Rodríguez, Clínico
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Planning for the study will be shared with potential sites pertaining to Spanish Network for Research in Infectious Disease (REIPI)for participation. IPD is not foreseen out of this groups due to the specific characteristics of patients and sites to be candidates for study participation.
IPD Sharing Time Frame
From starting to three years of study completion planification
IPD Sharing Access Criteria
Spanish Network for Research in Infectious Disease investigators
Citations:
PubMed Identifier
34580096
Citation
Marin-Candon A, Rosso-Fernandez CM, Bustos de Godoy N, Lopez-Cerero L, Gutierrez-Gutierrez B, Lopez-Cortes LE, Barrera Pulido L, Borreguero Borreguero I, Leon MJ, Merino V, Camean-Fernandez M, Retamar P, Salamanca E, Pascual A, Rodriguez-Bano J; ASTARTE Study Group. Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTE): protocol for a randomised, pragmatic trial. BMJ Open. 2021 Sep 27;11(9):e049481. doi: 10.1136/bmjopen-2021-049481.
Results Reference
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Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins

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