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

NCT04502095 | Completed Phase 4 FDA Drug

• 2 other identifiers: I 573720NCI-2020-04928
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Carcinoma; Refractory Bladder Carcinoma; Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Identify pre-operative factors associated with the development of UTI

  Up to 120 days after surgery

• Development of Clostridium difficile (C Diff)

  up to 120 days after surgery

• Infections occurring during antibiotic use

  Up to 120 days after surgery

• Identify post operative factors associated with the development of UTI

  Up to 120 days after surgery

Study Arms (2)

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)

EXPERIMENTAL

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; Other: Diary; Drug: Ertapenem; Drug: Levofloxacin; Drug: Nitrofurantoin; Drug: Trimethoprim-Sulfamethoxazole

Group II (standard of care)

ACTIVE COMPARATOR

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

Drug: Clindamycin; Drug: Ertapenem; Drug: Levofloxacin

Interventions

Clindamycin DRUG

Given PO

Also known as: Cleocin

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin); Group II (standard of care)

Diary OTHER

Complete drug diary

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)

Ertapenem DRUG

Given PO

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin); Group II (standard of care)

Levofloxacin DRUG

Given PO

Also known as: (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

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin); Group II (standard of care)

Nitrofurantoin DRUG

Given PO

Also known as: Macrobid, Macrodantin

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)

Trimethoprim-Sulfamethoxazole DRUG

Given PO

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

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urinary Tract Infections

Interventions

Clindamycin; Ertapenem; Levofloxacin; Ofloxacin; Nitrofurantoin; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Infections

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Nitrofurans; Nitro Compounds; Furans; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Khurshid A Guru

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 6, 2020
• Study Start: September 2, 2020
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Locations

US (1)