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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Enrolling; Phase 4

Conditions: Bloodstream Infection

Treatments: Drug: Long-treatment of any active antibiotic regimen; Drug: Short-treatment of any active antibiotic regimen

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05210439

2021-003847-10 (EudraCT Number)

SHORTEN II

Details and patient eligibility

About

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).

Full 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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

Short-treatment of any active antibiotic regimen

Experimental group

Description:

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

Treatment:

Drug: Short-treatment of any active antibiotic regimen

Long-treatment of any active antibiotic regimen

Active Comparator group

Description:

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

Treatment:

Drug: Long-treatment of any active antibiotic regimen