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

NCT ID: NCT03633643

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 728 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2022-10-31

Brief 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.

Detailed Description

Increasing antimicrobial resistance rates have a substantial impact on morbidity, mortality and healthcare costs and is particularly prevalent among urological patients due to an overuse of antimicrobial agents for therapeutical and prophylactic indications. Transurethral resection of the prostate is one of the most frequently performed urological procedures in Switzerland and a single-dose of antimicrobial prophylaxis is recommended to reduce postoperative urinary tract infections. For photoselective vaporisation of the prostate with the Greenlight Laser, a similar operative alternative, there are currently no international guidelines for antimicrobial prophylaxis.

The optimal duration of antimicrobial prophylaxis 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.

The study medication Cotrimoxazole (Trimethoprim/Sulfamethoxazole) is a routinely used antimicrobial substance recommended in international and in-house guidelines for antimicrobial prophylaxis and treatment of urinary tract infections. Perioperative antimicrobial prophylaxis will be Cotrimoxazole short infusion in both groups. Postoperative study medication packages consists of either five tablets of placebo or five tablets of Cotrimoxazole (Nopil forte®) 800/160mg using licensed product repacked in a new immediate container which is blinded

Conditions

Antimicrobial Prophylaxis in Prostate Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

Single-dose Trimethoprim (TMP)/sulfamethoxazole (SMX, i.e. Cotrimoxazole) perioperative as two ampoules of TMP/SMX 400/80 mg (Bactrim Inf Konz®) solved in 250 ml sodium chloride short infusion followed by five oral applications of placebo (lactose tablet; Fagron Gesellschaft mit beschränkter Haftung (GmbH) \& Co.KG) at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.

Group Type: PLACEBO_COMPARATOR

oral applications of Placebo

Intervention Type: DRUG

five oral applications of Placebo at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.

Group B

3-day application with TMP/SMX (i.e. Cotrimoxazole): Preoperatively as two ampoules of TMP/SMX 400/80mg (Bactrim Inf Konz®) solved in 250 ml sodium chloride short infusion, followed by five oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.

Group Type: ACTIVE_COMPARATOR

oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)

Intervention Type: DRUG

five oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) at the evening of the surgery and thereafter twice daily on day

1 and 2 after surgery while the patient is in hospital.

Interventions

oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)

five oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) at the evening of the surgery and thereafter twice daily on day

1 and 2 after surgery while the patient is in hospital.

Intervention Type: DRUG

oral applications of Placebo

five oral applications of Placebo at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Widmer, Prof.,MD,Dr.

Role: PRINCIPAL_INVESTIGATOR

Division of Infectious Diseases and Hospital Epidemiology

Locations

St. Claraspital, Department of Urology

Basel, Canton of Basel-City, Switzerland

Kantonsspital Aarau, Department of Urology

Aarau, , Switzerland

University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Basel, , Switzerland

Kantonsspital Baselland, Department of Urology

Liestal, , Switzerland

University Hospital Zurich, Department of Urology

Zurich, , Switzerland

Countries

Switzerland

References

Speich B, Bausch K, Roth JA, Hemkens LG, Ewald H, Vogt DR, Bruni N, Deuster S, Seifert HH, Widmer AF. Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial). Trials. 2019 Feb 19;20(1):142. doi: 10.1186/s13063-019-3237-3.

Reference Type: DERIVED

PMID: 30782183 (View on PubMed)

Other Identifiers

2018-0104; me17Widmer

Identifier Type: -

Identifier Source: org_study_id