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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
First received
Last updated
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
Health authority
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

Study Design


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
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