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Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia (SHORTEN2)

Primary Purpose

Bloodstream Infection

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Short-treatment of any active antibiotic regimen
Long-treatment of any active antibiotic regimen
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 Bloodstream Infection focused on measuring Bacteremia, Pseudomonas aeruginosa, Bloodstream infection, DOOR / RADAR Analysis, Antimicrobial stewardship

Eligibility Criteria

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

Main inclusion criteria:

  • Adult patients with diagnosis of BSI-PA who have received 6 days (+/- 1) of active antibiotic treatment from the date of extraction of the first positive blood culture and until the moment of randomization.
  • Informed consent signed.

Main exclusion criteria:

  • Bacteremia source not adequately controlled at least 72h before randomization.
  • Bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment more than 7 days
  • Coexistence of a different infection at the time of diagnosis of bacteremia that also requires antibiotic treatment.
  • Bacteremic pneumonia in severely immunosuppressed patients
  • Bacteremia of any origin in patients with severe neutropenia (<500 cells / mm3) at the time of randomization.

Sites / Locations

  • Hospital Universitario Central de AsturiasRecruiting
  • Hospital Universitario de BellvitgeRecruiting
  • Hospital Universitario Parc Taulí
  • Hospital Universitario de Cruces
  • Hospital Universitario de Jerez de la FronteraRecruiting
  • Hospital Universitario de Puerto RealRecruiting
  • Hospital Universitario de DonostiaRecruiting
  • Hospital Universitario Son EspasesRecruiting
  • Hospital San PedroRecruiting
  • Hospital Costa del Sol
  • Complexo Hospitalario Universitario de Vigo
  • Hospital Universitario de A CoruñaRecruiting
  • Complejo Hospitalario TorrecárdenasRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • Hospital Universitario Reina SofíaRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Universitario Clínico San CecilioRecruiting
  • Hospital Universitario Juan Ramón JiménezRecruiting
  • Complejo Hospitalario Ciudad de JaénRecruiting
  • Hospital Universitario Lucus AugustiRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Regional de MálagaRecruiting
  • Hospital Universitario Virgen de la Victoria
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Universitario Virgen de ValmeRecruiting
  • Hospital Universitario La FeRecruiting
  • Hospital Universitario Lozano BlesaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short-treatment of any active antibiotic regimen

Long-treatment of any active antibiotic regimen

Arm Description

7 days of any active antibiotic treatment from the date of the last positive blood culture

14 days of any active antibiotic treatment from the date of the last positive blood culture

Outcomes

Primary Outcome Measures

Probability of achieving better DOOR/RADAR score for patients in the experimental group than in the control group
Probability of any given patient in the experimental arm to achieve better results than a patient in the control group assessed through their score in the DOOR/RADAR ( Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk) analysis. This analysis categorizes patients in two steps: A first ordinal clinical outcome ranking (DOOR), defined by the following mutually excluding categories: Healing without incidences. Healing with a proven or probable recurrence. Healing with a serious adverse event. No clinical cure. Death. A second classification in which patients from the same clinical outcome category are ranked according to the number of days of antibiotic treatment (RADAR). Patients with a lower DOOR/RADAR score will be those with best outcomes in terms of clinical effectiveness as well as reduced exposure to antibiotic treatment.

Secondary Outcome Measures

Non-inferiority secondary endpoint; Treatment failure
Defined as mortality from any cause or proven/probable recurrence
Recurrence of infection
Proven, probable or possible recurrence rate
Mortality from any cause
Number of patients who dead from any cause from the date of inclusion to final follo-up period
Describe the superinfections
Superinfection rate
Safety of antibiotic treatment
Gathering any related adverse event from the informed consent form signature up to 90 days
Efficiency of the short-treatment arm
Number of days of treatment and days of hospital stay avoided at the end of the follow-up period
Confirmation of origin of recurrences
Checking if the recurrences are due to the same strain, comparing the P. aeruginosa strains by genetic sequencing
Comparison of ecological impact of short and long treatment regimens
Diversity of the gut microbiota analysis

Full Information

First Posted
January 14, 2022
Last Updated
May 3, 2023
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Spanish Clinical Research Network - SCReN, CIBER (Infectious diseases)
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1. Study Identification

Unique Protocol Identification Number
NCT05210439
Brief Title
Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia
Acronym
SHORTEN2
Official Title
Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteremia: a Multicenter, Randomized Clinical Trial (SHORTEN-2) With a DOOR / RADAR Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
September 2025 (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 Clinical Research Network - SCReN, CIBER (Infectious diseases)

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
Phase IV, open-labeled, randomized and multicenter clinical trial to demonstrate the superiority of antibiotics with authorized indication for 7 days versus 14 days in the treatment of bloodstream infections produced by P. aeruginosa (BSI-PA).
Detailed Description
The project is designed to determine the optimal duration of antibiotic treatment for Pseudomonas aeruginosa bacteremia, by comparing an adequate antibiotic treatment regimen of 7 days (experimental arm) with another of 14 days (control arm). The evaluation of infection recurrences, mortality, number of free days of antibiotic treatment, adverse events and superinfections are included as secondary objectives. Active antibiotic treatment will be considered any treatment with proven in vitro activity against the strain responsible for the patient's bacteremia, regardless of the administered dose. Clinical rules are included in order to stop antibiotic treatment or continuation and re-evaluation in each arm of treatment. This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 90 days after the first positive blood culture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bloodstream Infection
Keywords
Bacteremia, Pseudomonas aeruginosa, Bloodstream infection, DOOR / RADAR Analysis, Antimicrobial stewardship

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Randomized 1:1 to experimental group (short-treatment arm):control group (long-treatment arm)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short-treatment of any active antibiotic regimen
Arm Type
Experimental
Arm Description
7 days of any active antibiotic treatment from the date of the last positive blood culture
Arm Title
Long-treatment of any active antibiotic regimen
Arm Type
Active Comparator
Arm Description
14 days of any active antibiotic treatment from the date of the last positive blood culture
Intervention Type
Drug
Intervention Name(s)
Short-treatment of any active antibiotic regimen
Other Intervention Name(s)
Any active antibiotic with treatment with proven in vitro activity from a pre-stablished list of antibiotics included
Intervention Description
7 days of any active antibiotic treatment for BSI-PA
Intervention Type
Drug
Intervention Name(s)
Long-treatment of any active antibiotic regimen
Other Intervention Name(s)
Any active antibiotic with treatment with proven in vitro activity a pre-stablished list of antibiotics included
Intervention Description
14 days of any active antibiotic treatment for BSI-PA
Primary Outcome Measure Information:
Title
Probability of achieving better DOOR/RADAR score for patients in the experimental group than in the control group
Description
Probability of any given patient in the experimental arm to achieve better results than a patient in the control group assessed through their score in the DOOR/RADAR ( Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk) analysis. This analysis categorizes patients in two steps: A first ordinal clinical outcome ranking (DOOR), defined by the following mutually excluding categories: Healing without incidences. Healing with a proven or probable recurrence. Healing with a serious adverse event. No clinical cure. Death. A second classification in which patients from the same clinical outcome category are ranked according to the number of days of antibiotic treatment (RADAR). Patients with a lower DOOR/RADAR score will be those with best outcomes in terms of clinical effectiveness as well as reduced exposure to antibiotic treatment.
Time Frame
30 days after treatment withdrawal
Secondary Outcome Measure Information:
Title
Non-inferiority secondary endpoint; Treatment failure
Description
Defined as mortality from any cause or proven/probable recurrence
Time Frame
Day +30 from trial treatment interruption
Title
Recurrence of infection
Description
Proven, probable or possible recurrence rate
Time Frame
Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.
Title
Mortality from any cause
Description
Number of patients who dead from any cause from the date of inclusion to final follo-up period
Time Frame
Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.
Title
Describe the superinfections
Description
Superinfection rate
Time Frame
Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.
Title
Safety of antibiotic treatment
Description
Gathering any related adverse event from the informed consent form signature up to 90 days
Time Frame
Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture and weighted by 1,000 days of follow-up.
Title
Efficiency of the short-treatment arm
Description
Number of days of treatment and days of hospital stay avoided at the end of the follow-up period
Time Frame
Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.
Title
Confirmation of origin of recurrences
Description
Checking if the recurrences are due to the same strain, comparing the P. aeruginosa strains by genetic sequencing
Time Frame
Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.
Title
Comparison of ecological impact of short and long treatment regimens
Description
Diversity of the gut microbiota analysis
Time Frame
Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion criteria: Adult patients with diagnosis of BSI-PA who have received 6 days (+/- 1) of active antibiotic treatment from the date of extraction of the first positive blood culture and until the moment of randomization. Informed consent signed. Main exclusion criteria: Bacteremia source not adequately controlled at least 72h before randomization. Bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment more than 7 days Coexistence of a different infection at the time of diagnosis of bacteremia that also requires antibiotic treatment. Bacteremic pneumonia in severely immunosuppressed patients Bacteremia of any origin in patients with severe neutropenia (<500 cells / mm3) at the time of randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clara M Rosso Fernández, MD-PhD
Phone
+34955013414
Email
claram.rosso.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Molina Bermejo, MD-PhD
Email
josemolinagb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Miguel Cisneros Herreros, MD-PhD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocío
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilio García Prieto, Dr.
Email
egarciaprieto@gmail.com
First Name & Middle Initial & Last Name & Degree
Emilio García Prieto, Dr.
Facility Name
Hospital Universitario de Bellvitge
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireia Puig Asensio, Dr.
Email
mpuiga@bellvitgehospital.cat
First Name & Middle Initial & Last Name & Degree
Mireia Puig Asensio, Dr.
Facility Name
Hospital Universitario Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aina Gomila Grange, Dr.
Email
agomilagrange@gmail.com
First Name & Middle Initial & Last Name & Degree
Aina Gomila Grange, Dr.
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ane Josune Goikoetxea Agirre, Dr.
Email
ANEJOSUNE.GOIKOETXEAAGIRRE@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Itziar Rasines Delgado
Phone
+34946006000
Ext
2330
Email
Secretaria.infecciososCruces@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Ane Josune Goikoetxea Agirre, Dr.
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
Antonio Jesús Hidalgo, Dr.
Email
antonio_jesus_hidalgo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Antonio Jesús Hidalgo, Dr.
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
Patricia Jiménez Aguilar, Dr.
Email
patriciajaguilar@gmail.com
First Name & Middle Initial & Last Name & Degree
Patricia Jiménez Aguilar, Dr.
Facility Name
Hospital Universitario de Donostia
City
Donostia
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maialen Ibarguren Pinilla, Dr.
Email
maialen.ibargurenpinilla@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Maialen Ibarguren Pinilla, Dr.
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helem Haydee Vílchez Rueda, Dr.
Email
helemh.vilchez@ssib.es
First Name & Middle Initial & Last Name & Degree
Helem Haydee Vílchez Rueda, Dr.
Facility Name
Hospital San Pedro
City
Logroño
State/Province
La Rioja
ZIP/Postal Code
26006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Antonio Oteo Revuelta, Dr.
Email
Jaoteo@riojasalud.es
First Name & Middle Initial & Last Name & Degree
José Antonio Oteo Revuelta, Dr.
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso del Arco Jiménez, Dr.
Email
alfarco@gmail.com
First Name & Middle Initial & Last Name & Degree
Alfonso del Arco Jiménez, Dr.
Facility Name
Complexo Hospitalario Universitario de Vigo
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36213
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrián Sousa Domínguez, Dr.
Email
asousadominguez@gmail.com
First Name & Middle Initial & Last Name & Degree
Adrián Sousa Domínguez, Dr.
Facility Name
Hospital Universitario de A 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, Dr.
Email
Dolores.Sousa.Regueiro@sergas.es
First Name & Middle Initial & Last Name & Degree
Dolores Sousa Regueiro, Dr.
Facility Name
Complejo Hospitalario Torrecárdenas
City
Almería
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Ángeles Esteban Moreno, Dr.
Email
mariaa.esteban.moreno.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
María Ángeles Esteban Moreno, Dr.
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibai Los Arcos Bertiz, Dr.
Email
ibai.los_arcos@vhir.org
First Name & Middle Initial & Last Name & Degree
Ibai Los Arcos Bertiz, Dr.
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
Juan José Castón Osorio, Dr.
Email
juanj.caston.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Juan José Castón Osorio, Dr.
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 Zúñiga, Dr.
Email
miguelangellopezzuniga@gmail.com
First Name & Middle Initial & Last Name & Degree
Miguel Ángel López Zúñiga, Dr.
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
Francisco Anguita Santos, Dr.
Email
miparedro@gmail.com
First Name & Middle Initial & Last Name & Degree
Francisco Anguita Santos, Dr.
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
María Franco Huerta, Dr.
Email
mmfrancohuerta@gmail.com
First Name & Middle Initial & Last Name & Degree
María Franco Huerta, Dr.
Facility Name
Complejo Hospitalario Ciudad de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Herrero Rodríguez, Dr.
Email
gonees.data@hotmail.es
First Name & Middle Initial & Last Name & Degree
Carmen Herrero Rodríguez, Dr.
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Romay Lema, Dr.
Email
eva.maria.romay.lema@gmail.com
First Name & Middle Initial & Last Name & Degree
Eva Romay Lema, Dr.
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
Pilar Martín Dávila, Dr.
Email
pmartindav@gmail.com
First Name & Middle Initial & Last Name & Degree
Pilar Martín Dávila, Dr.
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belén Loeches Yagüe, Dr.
Email
bloeches@yahoo.es
First Name & Middle Initial & Last Name & Degree
Belén Loeches Yagüe, Dr.
Facility Name
Hospital Universitario Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Diego Ruiz Mesa, Dr.
Email
jdruizmesa@hotmail.com
First Name & Middle Initial & Last Name & Degree
Juan Diego Ruiz Mesa, Dr.
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario Palacios Muñoz, Dr.
Email
rosariopalaci@gmail.com
First Name & Middle Initial & Last Name & Degree
Rosario Palacios Muñoz, Dr.
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia González
Email
claudia.gonzalez@scsalud.es
First Name & Middle Initial & Last Name & Degree
Mª Carmen Fariñas, Dr.
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
Luis Eduardo López Cortés, Dr.
Email
luiselopezcortes@gmail.com
First Name & Middle Initial & Last Name & Degree
Luis Eduardo López Cortés, Dr.
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
Rocío Álvarez, MD
Email
rocioalma@gmail.com
First Name & Middle Initial & Last Name & Degree
Rocío Álvarez, MD
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
Nicolás Merchante Gutiérrez, Dr.
Email
nicolasmerchante@gmail.com
First Name & Middle Initial & Last Name & Degree
Nicolás Merchante Gutiérrez, Dr.
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Ramírez Galleymore, Dr.
Email
paula.ramirez.galleymore@gmail.com
First Name & Middle Initial & Last Name & Degree
Paula Ramírez Galleymore, Dr.
Facility Name
Hospital Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Ramón Paño Pardo, Dr.
Email
joserrapa@gmail.com
First Name & Middle Initial & Last Name & Degree
José Ramón Paño Pardo, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Final database containing only anonymous data from participant subjects will be shared with direct investigators in a timeframe of 6 months after the complete depuration
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
Direct collaborators within the study

Learn more about this trial

Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia

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