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

Study acronym: SHORTEN2
StatusActive, Not Recruiting
PhasePhase 4
Started2022-04-28
View on ClinicalTrials.gov ↗

Amendment history

2026-01-20
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2025-06→confirmed 2025-12-01
Completion date2025-09→2026-06
Study sitesdetails revised at 37 of 37 sites
2024-06-19
minor
Study Status, Outcome Measures, Contacts/Locations v6
Secondary endpointsdetails revised at 1 of 8 entries
Study sitesdetails revised at 1 of 37 sites
2024-03-01
minor
Study Status, Contacts/Locations, References v5
Study sites30→37
Publicationsdetails revised at 1 of 1 entry
2023-05-03
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 24 of 30 sites
2022-05-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04→confirmed 2022-04-28
Study sitesdetails revised at 30 of 30 sites
Show 2 earlier versions
2022-04-12
minor
Study Status, Eligibility, Contacts/Locations v2
Eligibility criteria+8 characters
[...] nformed consent signed. Main exclusion criteria: Bacteremia focussource not adequately controlled at least 72h before randomization. Bacteremia secondary to an infection that nec [...] n at the time of diagnosis of bacteremia that also requires prolonged antibiotic treatment. Bacteremic pneumonia in severely immun [...]
Study sitescontacts updated at 1 of 30 sites
2022-03-31
minor
Study Status v1
Start date2022-02→2022-04
2022-01-14
minor
Original filing
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).
Trial Details
NCT Number NCT05210439
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators: Spanish Clinical Research Network - SCReN, Centers for International Business Education and Research
Conditions Bloodstream Infection
Enrollment 306 participants
Start Date 2022-04-28
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-22