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

NCT04502095 | Completed Phase 4 Results 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)

• Number of Participants With Urinary Tract Infection (UTI)

  The number of paticipants who experienced UTI (primary outcome) within 90 days after cystectomy is reported for each group.

  At 90 days after surgery

Secondary Outcomes (1)

• Number of Participants With Infection

  Up to 90 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

Related Publications (1)

• Hussein AA, Mahmood AW, Ahmad A, Houenstein H, Harrington G, Khan M, Abdelhaq D, Jing Z, Attwood K, Almyroudis NG, Li Q, Guru KA. Do Prophylactic Antibiotics Decrease the Rate of Urinary Tract Infections After Robot-Assisted Radical Cystectomy? A Randomized Controlled Trial. J Urol. 2025 Aug;214(2):147-155. doi: 10.1097/JU.0000000000004586. Epub 2025 Apr 25.

  PMID: 40279497 DERIVED

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

Limitations and Caveats

* 1 The antibiotics chosen for prophylaxis were selected based on institutional data, and therefore, might vary from others. * 2 Patients who were discharged with drugs that may cause QT prolongation, or discharged on antibiotics, were not evaluated in current study. * 3 The lack of a placebo in the control group and also the clinicians being not blinded to the treatment group might have introduced some bias. * 4 Despite randomization, more females were included in the standard of care group.

Results Point of Contact

• Title: Khurshid Guru, MD. Chair of Urology
• Organization: Roswell Park Comprehensive Cancer Center

Khurshid.Guru@RoswellPark.org

(716)845-4107

Study Officials

• Khurshid A Guru

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: September 29, 2026
• Results First Posted: September 29, 2026

Record last verified: 2026-08

Locations

US (1)