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Completed

NCT Number: NCT04502095

Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

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Key information

Conditions

Bladder Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Neoplasms Neoplasms by Site Refractory Bladder Carcinoma Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Tract Infection Urinary Tract Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

PRIMARY OBJECTIVE:

I. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy.

SECONDARY OBJECTIVE:

I. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ANTIBIOTIC): Patients receive ertapenem Intravenously (IV), levofloxacin, or clindamycin IV at induction per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

GROUP II (CONTROL): Patients receive ertapenem IV, levofloxacin IV or clindamycin IV at induction per standard of care.

After surgery, patients are followed up to 120 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient that electively chooses to have a cystectomy is eligible to participate in the study. Indications for a person who may undergo a cystectomy include having a diagnosis of muscle-invasive bladder cancer (MIBC) or refractory non-muscle invasive bladder cancer (NMIBC)
  • Any patient that will electively choose to have a robot-assisted radical cystectomy and is able to provide consent
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion criteria

  • Patients with a history of myasthenia gravis
  • Patients with a history of QT prolongation or taking other drugs that prolong corrected QTc (QTc) should be excluded
  • Patients with renal dysfunction, creatinine clearance (mL/min) < 30
  • Pregnant or nursing female participants
  • Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC)
  • Unwilling or unable to follow protocol requirements
  • Patients who receive a prophylactic antibiotic or antibiotic for any other reason prior to discharge
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Treatment and study plan

Clindamycin

Drug

Given PO

Other names: Cleocin

Diary

Other

Complete drug diary

Ertapenem

Drug

Given PO

Levofloxacin

Drug

Given PO

Other names: (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid Hydrate (2:1), Levaquin, Levofloxacin Hydrate, Quixin

Nitrofurantoin

Drug

Given PO

Other names: Macrobid, Macrodantin

Trimethoprim-sulfamethoxazole

Drug

Given PO

Other names: Bactrim, Bactrim DS, Bactrimel, Centran, Centrin, Co-Trimoxazole, Cotrim, Cotrimoxazole, Eslectin, Insozalin, Septra, SMZ-TMP, Sulfamethoprim, Sulfatrim, Sulmeprim, TMP-SMX, Trimedin, Trimezole, Uroplus

Primary outcomes

  1. 90-day urinary tract infection (UTI) status

    Time frame: At 90 days after surgery

    Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.

Secondary outcomes

  1. Identify pre-operative factors associated with the development of UTI

    Time frame: Up to 120 days after surgery

    stratified logistic regression models (stratified by antibiotic use)

  2. Development of Clostridium difficile (C Diff)

    Time frame: up to 120 days after surgery

    Will be evaluated in patients who received prophylactic antibiotics.

  3. Infections occurring during antibiotic use

    Time frame: Up to 120 days after surgery

    To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively.

  4. Identify post operative factors associated with the development of UTI

    Time frame: Up to 120 days after surgery

    stratified logistic regression models (stratified by antibiotic use)

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2020
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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