Overview

Cotrimoxazole Prophylaxis in Transurethral Resection or Greenlight Laser Vaporisation of the Prostate

Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
0
Participant gender:
Male
Summary
The optimal duration of antimicrobial prophylaxis (study medication Cotrimoxazole (Trimethoprim/Sulfamethoxazole)) in transurethral resection of the prostate and Greenlight Laser vaporisation of the prostate is investigated by comparing a guideline-conform single-dose prophylaxis (intervention) versus usual clinical care (i.e. 3-day prophylaxis; control) for prevention of urinary tract infections.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborator:
Swiss National Science Foundation
Treatments:
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
Inclusion Criteria:

- Obstructive voiding disorder (e.g. benign prostate hyperplasia, obstructive prostate
cancer)

- Planned Transurethral resection of the prostate (TURP) or Greenlight Laser (GL)

Exclusion Criteria:

- Evidence for (catheter associated-) UTI, with or without antibiotic treatment in the
last 7 days prior to randomisation.

- Any evidence of a history of positive urine culture (cfu ³105/ml in midstream-urine
with no more than two species) and resistance to TMP/SMX in the last 7 days prior to
randomisation.

- Known contraindication against study drugs according to the Swissmedic package leaflet
(e.g. known liver dysfunction, renal insufficiency; patients with glomerular
filtration rate (calculated by the Modification of Diet in Renal Disease (MDRD) or
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <30ml/min or dialysis
patients will be excluded).

- Antibiotic treatment for any reason within 7 days prior to randomisation

- Indication for Antibiotic prophylaxis (AP) for other reasons (e.g. endocarditis
prophylaxis, transplanted patients under systemic immunosuppression).