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

Primary Purpose

Bladder Carcinoma, Refractory Bladder Carcinoma, Urinary Tract Infection

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clindamycin
Diary
Ertapenem
Levofloxacin
Nitrofurantoin
Trimethoprim-Sulfamethoxazole
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)

Group II (standard of care)

Arm Description

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.

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

Outcomes

Primary Outcome Measures

90-day urinary tract infection (UTI) status
Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.

Secondary Outcome Measures

Identify pre-operative factors associated with the development of UTI
stratified logistic regression models (stratified by antibiotic use)
Development of Clostridium difficile (C Diff)
Will be evaluated in patients who received prophylactic antibiotics.
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.
Identify post operative factors associated with the development of UTI
stratified logistic regression models (stratified by antibiotic use)

Full Information

First Posted
July 24, 2020
Last Updated
January 26, 2023
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04502095
Brief Title
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
Official Title
Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
September 2, 2024 (Anticipated)
Study Completion Date
September 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Carcinoma, Refractory Bladder Carcinoma, Urinary Tract Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Other Intervention Name(s)
Cleocin
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Diary
Intervention Description
Complete drug diary
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
(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
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Other Intervention Name(s)
Macrobid, Macrodantin
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Trimethoprim-Sulfamethoxazole
Other Intervention Name(s)
Bactrim, Bactrim DS, Bactrimel, Centran, Centrin, Co-Trimoxazole, Cotrim, Cotrimoxazole, Eslectin, Insozalin, Septra, SMZ-TMP, Sulfamethoprim, Sulfatrim, Sulmeprim, TMP-SMX, Trimedin, Trimezole, Uroplus
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
90-day urinary tract infection (UTI) status
Description
Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.
Time Frame
At 90 days after surgery
Secondary Outcome Measure Information:
Title
Identify pre-operative factors associated with the development of UTI
Description
stratified logistic regression models (stratified by antibiotic use)
Time Frame
Up to 120 days after surgery
Title
Development of Clostridium difficile (C Diff)
Description
Will be evaluated in patients who received prophylactic antibiotics.
Time Frame
up to 120 days after surgery
Title
Infections occurring during antibiotic use
Description
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.
Time Frame
Up to 120 days after surgery
Title
Identify post operative factors associated with the development of UTI
Description
stratified logistic regression models (stratified by antibiotic use)
Time Frame
Up to 120 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khurshid A Guru
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khurshid A. Guru
Phone
716-845-4107
Email
Khurshid.Guru@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Khurshid A. Guru

12. IPD Sharing Statement

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

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