NCT04502095CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 89 (actual)
- First submitted
- 24 Jul 2020
- Start date
- 2 Sept 2020
- Primary completion date
- 13 Mar 2025
- Lead sponsor
- Roswell Park Cancer Institute
- Diseases
- Bladder cancer
- NCT number
- NCT04502095
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 89
- From 2 Sept 2020 to the primary completion date, 13 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who receive a prophylactic antibiotic or antibiotic for any other reason prior to discharge
Other illness
- Patients with a history of myasthenia gravis
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Lab values
- 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
Other
- Pregnant or nursing female participants
- Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC)
- Unwilling or unable to follow protocol requirements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.