Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia
- Conditions
- Bloodstream Infection
- Interventions
- Drug: Short-treatment of any active antibiotic regimenDrug: Long-treatment of any active antibiotic regimen
- Registration Number
- NCT05210439
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 306
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short-treatment of any active antibiotic regimen Short-treatment of any active antibiotic regimen 7 days of any active antibiotic treatment from the date of the last positive blood culture Long-treatment of any active antibiotic regimen Long-treatment of any active antibiotic regimen 14 days of any active antibiotic treatment from the date of the last positive blood culture
- Primary Outcome Measures
Name Time Method Probability of achieving better DOOR/RADAR score for patients in the experimental group than in the control group 30 days after treatment withdrawal 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.
- Secondary Outcome Measures
Name Time Method Non-inferiority secondary endpoint; Treatment failure Day +30 from trial treatment interruption Defined as mortality from any cause or proven/probable recurrence
Recurrence of infection Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. Proven, probable or possible recurrence rate
Describe the superinfections Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. Superinfection rate
Confirmation of origin of recurrences Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. Checking if the recurrences are due to the same strain, comparing the P. aeruginosa strains by genetic sequencing
Mortality from any cause Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. Number of patients who died from any cause from the date of inclusion to the final follow-up period
Safety of antibiotic treatment 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. Gathering any related adverse event from the informed consent form signature up to 90 days
Efficiency of the short-treatment arm Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. Number of days of treatment and days of hospital stay avoided at the end of the follow-up period
Comparison of ecological impact of short and long treatment regimens Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. Diversity of the gut microbiota analysis
Trial Locations
- Locations (37)
Hospital San Pedro
🇪🇸Logroño, La Rioja, Spain
Hospital Universitario de Donostia
🇪🇸Donostia, Gipuzkoa, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Complexo Hospitalario Universitario de Vigo
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario de A Coruña
🇪🇸A Coruña, Spain
Complejo Hospitalario Ciudad de Jaén
🇪🇸Jaén, Spain
Hospital Universitario de Cruces
🇪🇸Barakaldo, Bizkaia, Spain
Complejo Hospitalario Torrecárdenas
🇪🇸Almería, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cadiz, Spain
Hospital Universitario de Bellvitge
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitario de Puerto Real
🇪🇸Puerto Real, Cádiz, Spain
Hospital Universitario de Jerez de la Frontera
🇪🇸Jerez De La Frontera, Cádiz, Spain
Hospital Universitario Son Espases
🇪🇸Palma De Mallorca, Islas Baleares, Spain
Hospital Costa del Sol
🇪🇸Marbella, Málaga, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital General Universitario Dr. Balmis
🇪🇸Alicante, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Universitario Clínico San Cecilio
🇪🇸Granada, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Regional de Málaga
🇪🇸Málaga, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain