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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
7 days of any active antibiotic treatment for BSI-PA
14 days of any active antibiotic treatment for BSI-PA
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: 1. A first ordinal clinical outcome ranking (DOOR), defined by the following mutually excluding categories: 1. Healing without incidences. 2. Healing with a proven or probable recurrence. 3. Healing with a serious adverse event. 4. No clinical cure. 5. Death. 2. 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
Non-inferiority secondary endpoint; Treatment failure
Defined as mortality from any cause or proven/probable recurrence
Time frame: Day +30 from trial treatment interruption
Recurrence of infection
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.
Mortality from any cause
Number of patients who died from any cause from the date of inclusion to the final 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.
Describe the superinfections
Superinfection rate
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Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario de Puerto Real
Puerto Real, Cádiz, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
...and 27 more locations
Time frame: Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.
Safety of antibiotic treatment
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.
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
Time frame: Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.
Confirmation of origin of recurrences
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.
Comparison of ecological impact of short and long treatment regimens
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.