2023-508441-41-00
Not yet recruiting
Phase 4
Efficacy and safety of 7 versus 14 days of antibiotic treatment for bacteremia produced by Pseudomonas aeruginosa: a multicenter, randomized (SHORTEN-2) clinical trial with a DOOR/RADAR analysis.
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla37 sites in 1 country306 target enrollmentStarted: July 8, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 306
- Locations
- 37
- Primary Endpoint
- Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up: Day +30 after the end of aproppriate antibiotic treatment.
Overview
Brief Summary
Determine if a 7-day antibiotic treatment regimen is superior to a 14-day regimen in the treatment of P. aeruginosa bacteremia, evaluating in an integrated manner both the effectiveness of the short regime and its potential to reduce serious adverse events and antibiotic exposure.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (18 years or older).
- •Present bacteremia due to P. aeruginosa.
- •Having received 6 days (+/-1) of active antibiotic treatment against bacteremia counted from the date of extraction of the first positive blood culture and until the moment of randomization.
- •Have signed the informed consent for the trial.
Exclusion Criteria
- •Minors under 18 years of age.
- •Polymicrobial bacteremia including microorganisms other than P. aeruginosa. Polymicrobial bacteremia is considered the isolation in blood of more than one bacteria other than P.aeruginosa with clinical significance. P.aeruginosa bacteremias that are accompanied by isolates considered as contaminations (coagulase-negative staphylococci or viridans group streptococci, etc.) without clinical significance can be recruited for the trial, since these will not require specific treatment, and should not be considered polymicrobial bacteremia for the purposes of the assay.
- •Patients in palliative care or with an expected survival of less than 48 hours at the time of randomization.
- •Bacteremia due to P. aeruginosa in the previous 30 days as long as the previous infection has not been resolved.
- •The doctor responsible for the patient does not want to include the patient in the clinical trial.
- •Pregnant or breastfeeding women. Potentially fertile patients must have a negative pregnancy test.
- •Focus of bacteremia not adequately controlled at least 72 hours before randomization.
- •Bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment, greater than 7 days, including: -Post-obstructive or necrotizing pneumonia. -Lung abscesses. -Acute prostatitis. -Bone and joint infections. -Central nervous system infections. -Endovascular infections related to vascular prostheses. -Any other at the discretion of the doctor responsible for the patient.
- •Coexistence of a different infection at the time of diagnosis of bacteremia that also requires antibiotic treatment if their treatment will be extended beyond 7 days from the diagnosis of bacteremia by P. aeruginosa. On the contrary, in the event that an infection coexists whose treatment ends before randomization, the patient may be included. Also in case there are isolates other than P. aeruginosa in samples corresponding to colonizations that do not require antibiotic treatment (asymptomatic bacteriuria, contamination of blood cultures by colonizers usual, bronchoaspirates without symptoms or signs suggestive of infection respiratory), the patient may be included in the trial..
- •Bacteremic pneumonia in severely immunocompromised patients, defined as: -Patients with severe neutropenia (<500 cells/mm3). -Recipients of allogeneic hematopoietic stem cell or solid organ transplant, during the first year after the transplant. -Active graft-versus-host disease requiring immunosuppressive treatment. -Patients with solid tumors who are receiving chemotherapy. -Untreated HIV infection with CD4 < 200 cells/mm
Outcomes
Primary Outcomes
Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up: Day +30 after the end of aproppriate antibiotic treatment.
Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up: Day +30 after the end of aproppriate antibiotic treatment.
Secondary Outcomes
- All-cause mortality, clinical cure and treatment failure: Days +30 and +90 after the end of aproppriate antibiotic treatment.
- Superinfections, serious adverse events, days of hospital stay, and recurrences (proven, probable or possible): Day +90 after the end of aproppriate antibiotic treatment.
Investigators
Coordinadora/monitor médico y de seguridad.
Scientific
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Study Sites (37)
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