NCT04209192

Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB)

Completed Phase 2 Last updated 4 April 2023

What this trial tests

Phase 2 trial testing Fosfomycin Tromethamine 3G Sachet in Urinary Tract Infections in 75 participants. Completed in 1 April 2023.

Timeline

1 January 2020

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	75
Start date	1 January 2020
Primary completion	1 April 2023
Estimated completion	1 April 2023
Sites	1 location across Mexico

Drugs / interventions tested

• Fosfomycin Tromethamine 3G Sachet — full drug profile →
• Amikacin (AMIKACIN) — full drug profile →

Conditions studied

• Urinary Tract Infections — all drugs for Urinary Tract Infections →
• Bladder Cancer — all drugs for Bladder Cancer →
• Urologic Surgical Procedures — all drugs for Urologic Surgical Procedures →

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →

Who can join

18 and older, any sex, with Urinary Tract Infections or Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Antimicrobial prophylaxis in urological procedures is aimed to reduce the risk of local and systemic postoperative infections such as urinary tract infection or surgical site infection. It should be recommended only when the potential benefit exceeds the anticipated risks and costs. However, a wide variation in the use of periprocedural prophylactic antibiotics has been demonstrated, which frequently is incurred as an inappropriate selection of antimicrobials, inadequate schedule of administration or excessive duration of prophylaxis.

The increase in multidrug resistance of antibiotics in recent decades has been associated with its misuse, resulting in an increased rate of morbidity and mortality, prolonged hospital stays and increased care costs. Specifically, resistance to fluoroquinolones has increased its prevalence, a group of antibiotics widely used in urology. Therefore, local resistance patterns should be considered before following recommendations, especially in populations with poor control of antimicrobial use.

Transurethral resection of bladder (TURB) has become a frequent surgical procedure, as it is the main diagnostic and therapeutic tool for bladder cancer, representing the ninth most common malignancy in the world. However, no recent randomized clinical trial has investigated antimicrobial prophylaxis for TURB. It is well known that an expected complication of TURB is urinary tract infection (UTI), which is the most common healthcare related infection worldwide.

Under this premise, a randomized clinical trial is proposed to analyze the current panorama of UTI as a transcendent postoperative complication of TURB, under the context of the new emerging resistance parameters. The use of fosfomycin trometamol is proposed as a good potential option for urological procedures due to its high activity against multidrug-resistant gram-negative bacteria and its favorable pharmacokinetic parameters that guarantees wide tissue penetration and a high urinary concentration, in a single dose, the which will be compared with the control group with traditional prophylaxis (amikacin). The relative risk of UTI will be estimated, as well as the attributable risk of the main risk factors associated with this infection, allowing a better characterization of this population for adequate decision making regarding this clinical challenge.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.