Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Summary

The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis.

Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively.

The investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.

Conditions

• Cystectomy
• Bladder Cancer Requiring Cystectomy
• Postoperative Infections
• Antibiotic Prophylaxis
• Ileal Conduit

Interventions

DRUG

Pivmecillinam

Orally administered pivmecillinam 400mg

DRUG

Pivmecillinam

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Amoxicillin clavulanic acid

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Amoxicillin

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Cefuroxime

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Ciprofloxacin

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Linezolid

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Nitrofurantoin

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Trimethoprim

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Sulfamethoxazole trimethoprim

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Fluconazole

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Andreas Røder, Prof, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-07

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• Denmark

Study Locations