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

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection 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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Tract Infection; Bladder Carcinoma; Refractory Bladder Carcinoma
• Intervention / Treatment: Drug: Clindamycin; Other: Diary; Drug: Ertapenem; Drug: Levofloxacin; Drug: Nitrofurantoin; Drug: Trimethoprim-Sulfamethoxazole

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Cancer Institute
      • Contact: Khurshid A. Guru; Phone Number: 716-845-4107; Email: Khurshid.Guru@roswellpark.org
      • Principal Investigator: Khurshid A. Guru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin); Patients receive ertapenem 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.	Drug: Clindamycin; Given PO; Other Names: Cleocin; Other: Diary; Complete drug diary; Drug: Ertapenem; Given PO; Drug: Levofloxacin; Given PO; Other Names: Levaquin; (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); Levofloxacin Hydrate; Quixin; Drug: Nitrofurantoin; Given PO; Other Names: Macrobid; Macrodantin; Drug: Trimethoprim-Sulfamethoxazole; Given PO; Other Names: Bactrim; Septra; Sulfatrim; TMP-SMX; Bactrim DS; Bactrimel; Centran; Centrin; Co-Trimoxazole; Cotrim; Cotrimoxazole; Eslectin; Insozalin; SMZ-TMP; Sulfamethoprim; Sulmeprim; Trimedin; Trimezole; Uroplus
Active Comparator: Group II (standard of care); Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.	Drug: Clindamycin; Given PO; Other Names: Cleocin; Drug: Ertapenem; Given PO; Drug: Levofloxacin; Given PO; Other Names: Levaquin; (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); Levofloxacin Hydrate; Quixin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify pre-operative factors associated with the development of UTI	stratified logistic regression models (stratified by antibiotic use)	Up to 120 days after surgery
Development of Clostridium difficile (C Diff)	Will be evaluated in patients who received prophylactic antibiotics.	up to 120 days after surgery
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
Identify post operative factors associated with the development of UTI	stratified logistic regression models (stratified by antibiotic use)	Up to 120 days after surgery

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Khurshid A Guru, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Estimated): March 2, 2025
• Study Completion (Estimated): September 2, 2025

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma; Infections; Communicable Diseases; Urinary Bladder Neoplasms; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Cytochrome P-450 CYP2C8 Inhibitors; Clindamycin; Levofloxacin; Ofloxacin; Ertapenem; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination; Nitrofurantoin
• Other Study ID Numbers: I 573720 (Other Identifier: Roswell Park Cancer Institute); NCI-2020-04928 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes