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NCT04502095 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 4
Development phase
89
Enrollment target

NCT04502095: Completed Phase 4 study, sponsored by Roswell Park Cancer Institute.

NCT04502095 is a Phase 4 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 89 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04502095, a Phase 4 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 4
Development phase
89 participants
Enrollment target

Study 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.

Primary Outcome

Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.

Interventions

  • DRUG Clindamycin
  • DRUG Nitrofurantoin
  • DRUG Levofloxacin
  • OTHER Diary
  • DRUG Ertapenem

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2020-09-02
Est. Completion 2025-03-13
Phase Phase 4
Roswell Park Cancer Institute

365 total trials

What the finished NCT04502095 record still lists

NCT04502095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 5 interventions - of which Clindamycin is the first listed.

NCT04502095 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04502095 about?

NCT04502095 is a clinical study titled "Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy". 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...

What is the current status of trial NCT04502095?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 89 participants. The study started on 2020-09-02. Estimated completion is 2025-03-13.

What interventions are being tested in trial NCT04502095?

The interventions under investigation include: Clindamycin (DRUG), Nitrofurantoin (DRUG), Levofloxacin (DRUG), Diary (OTHER), Ertapenem (DRUG).

Who is sponsoring clinical trial NCT04502095?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04502095's enrollment target sits among peer trials

89 913th of 2000 higher than 1,085 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04502095, the US trial registry maintained by the National Library of Medicine. NCT04502095 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.