← Back to Search

Antibiotic

Antibiotics for Urinary Tract Infections After Bladder Surgery

Phase 4
Recruiting
Led By Khurshid A Guru
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient that will electively choose to have a robot-assisted radical cystectomy and is able to provide consent
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 90 days after surgery
Awards & highlights

Study Summary

This trial is testing whether a month of antibiotics can help reduce urinary infections after surgery to remove the bladder.

Who is the study for?
This trial is for patients planning to undergo robot-assisted surgery to remove the bladder due to muscle-invasive or refractory non-muscle invasive bladder cancer. Participants must understand and consent to the study's nature. Excluded are those with myasthenia gravis, QT prolongation, severe kidney issues, pregnant/nursing women, and anyone who can't follow the protocol.Check my eligibility
What is being tested?
The trial tests if a one-month course of antibiotics like trimethoprim-sulfamethoxazole or nitrofurantoin after robot-assisted radical cystectomy reduces urinary tract infections. It aims to improve post-surgery outcomes and manage complications better.See study design
What are the potential side effects?
Possible side effects from antibiotics may include allergic reactions, gastrointestinal upset (like nausea or diarrhea), potential organ inflammation, skin rashes, and increased resistance to antibiotics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I choose to have a robot-assisted surgery for bladder removal and can consent.
Select...
I am choosing to have a cystectomy for my bladder cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 90 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 90 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
90-day urinary tract infection (UTI) status
Secondary outcome measures
Development of Clostridium difficile (C Diff)
Identify post operative factors associated with the development of UTI
Identify pre-operative factors associated with the development of UTI
+1 more

Side effects data

From 2014 Phase 3 trial • 607 Patients • NCT00405704
14%
Fever
8%
Rash
6%
Pharyngitis
5%
Viral Infection
4%
Diarrhea
4%
Otitis Media
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trimethoprim-Sulfamethoxazole
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)Experimental Treatment6 Interventions
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: Group II (standard of care)Active Control3 Interventions
Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ertapenem
2011
Completed Phase 4
~8070
Clindamycin
2017
Completed Phase 4
~14740
Levofloxacin
2011
Completed Phase 4
~8180
Trimethoprim-Sulfamethoxazole
2010
Completed Phase 3
~1260
Nitrofurantoin
2011
Completed Phase 4
~3720

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
400 Previous Clinical Trials
30,699 Total Patients Enrolled
Khurshid A GuruPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
117 Total Patients Enrolled

Media Library

Clindamycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04502095 — Phase 4
Urinary Tract Infection Research Study Groups: Group II (standard of care), Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
Urinary Tract Infection Clinical Trial 2023: Clindamycin Highlights & Side Effects. Trial Name: NCT04502095 — Phase 4
Clindamycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502095 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common applications of Trimethoprim-Sulfamethoxazole?

"Trimethoprim-Sulfamethoxazole is a recommended medication for treating immune deficiency, bacterial wound infections and anaerobic bacteria."

Answered by AI

What is the current enrollment cap for this trial?

"Affirmative. Records hosted on clinicaltrials.gov indicate that this investigation, which was originally uploaded to the platform in September 2020, is enrolling patients currently. About 100 participants need to enrolled from a single medical centre."

Answered by AI

To what extent has Trimethoprim-Sulfamethoxazole been investigated in clinical trials?

"Presently, 59 scientific studies pertaining to Trimethoprim-Sulfamethoxazole are operational. Of these, 16 are in the third phase of clinical trials. The majority take place in Durham, North carolina; however, 609 sites across the country have active study centers for this drug treatment regimen."

Answered by AI

To what extent can Trimethoprim-Sulfamethoxazole be utilized without risk to individuals?

"The safety of Trimethoprim-Sulfamethoxazole was rated as a 3, since it is already approved for use in Phase 4 trials."

Answered by AI

Is this study still enrolling participants?

"Affirmative, the records from clinicaltrials.gov demonstrate that this experiment is currently searching for participants. This research project was originally uploaded on September 2nd 2020 and updated most recently on May 3rd 2022. There needs to be 100 patients recruited at one medical site."

Answered by AI
~10 spots leftby Sep 2024