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

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502095
• Other study ID #: I 573720
• Secondary ID: NCI-2020-04928I
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2, 2020
• Est. completion date: September 2, 2025

Study information

• Verified date: April 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 orally (PO), levofloxacin PO, or clindamycin PO induction therapy 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 PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

After surgery, patients are followed up to 120 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2, 2025
• Est. primary completion date: March 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Carcinoma
• Carcinoma
• Communicable Diseases
• Infections
• Refractory Bladder Carcinoma
• Urinary Bladder Neoplasms
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Clindamycin
Given PO

Other:
• Diary
Complete drug diary

Drug:
• Ertapenem
Given PO
• Levofloxacin
Given PO
• Nitrofurantoin
Given PO
• Trimethoprim-Sulfamethoxazole
Given PO

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day urinary tract infection (UTI) status	Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.	At 90 days after surgery
Secondary	Identify pre-operative factors associated with the development of UTI	stratified logistic regression models (stratified by antibiotic use)	Up to 120 days after surgery
Secondary	Development of Clostridium difficile (C Diff)	Will be evaluated in patients who received prophylactic antibiotics.	up to 120 days after surgery
Secondary	Infections occurring during antibiotic use	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.	Up to 120 days after surgery
Secondary	Identify post operative factors associated with the development of UTI	stratified logistic regression models (stratified by antibiotic use)	Up to 120 days after surgery