---
title: Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
nct_id: NCT04502095
overall_status: COMPLETED
phase: PHASE4
sponsor: Roswell Park Cancer Institute
study_type: INTERVENTIONAL
primary_condition: Bladder Carcinoma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04502095.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04502095"
ct_last_update_post_date: 2025-08-03
last_seen_at: "2026-05-12T06:27:21.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04502095](https://clinicaltrials.gov/study/NCT04502095)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 89
- **Lead Sponsor:** Roswell Park Cancer Institute
- **Conditions:** Bladder Carcinoma, Refractory Bladder Carcinoma, Urinary Tract Infection
- **Start Date:** 2020-09-02
- **Completion Date:** 2025-03-13
- **CT.gov Last Update:** 2025-08-03

## 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 Intravenously (IV), levofloxacin, or clindamycin IV at induction 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 IV, levofloxacin IV or clindamycin IV at induction per standard of care.

After surgery, patients are followed up to 120 days.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **Group II (standard of care)** (ACTIVE_COMPARATOR) — Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

## Interventions

- **Clindamycin** (DRUG) — Given PO
- **Diary** (OTHER) — Complete drug diary
- **Ertapenem** (DRUG) — Given PO
- **Levofloxacin** (DRUG) — Given PO
- **Nitrofurantoin** (DRUG) — Given PO
- **Trimethoprim-Sulfamethoxazole** (DRUG) — Given PO

## Primary Outcomes

- **90-day urinary tract infection (UTI) status** _(time frame: At 90 days after surgery)_ — Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.

## Secondary Outcomes

- **Identify pre-operative factors associated with the development of UTI** _(time frame: Up to 120 days after surgery)_
- **Development of Clostridium difficile (C Diff)** _(time frame: up to 120 days after surgery)_
- **Infections occurring during antibiotic use** _(time frame: Up to 120 days after surgery)_
- **Identify post operative factors associated with the development of UTI** _(time frame: Up to 120 days after surgery)_

## Locations (1)

- Roswell Park Cancer Institute, Buffalo, New York, United States

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.roswell park cancer institute|buffalo|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04502095.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04502095*  
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