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Antibiotic
Antibiotics for Urinary Tract Infections After Bladder Surgery
Phase 4
Waitlist Available
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
Be older than 18 years old
Must not have
Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC)
Patients with renal dysfunction, creatinine clearance (mL/min) < 30
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 90 days after surgery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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.
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.
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
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am a woman who had a fertility-preserving bladder surgery.
Select...
My kidney function is low, with a creatinine clearance under 30 mL/min.
Select...
I do not have a history of abnormal heart rhythms nor take medication that affects it.
Select...
I was given antibiotics before leaving the hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 90 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 90 days after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
90-day urinary tract infection (UTI) status
Secondary study objectives
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 moreSide effects data
From 2014 Phase 3 trial • 607 Patients • NCT0040570414%
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
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Trimethoprim-Sulfamethoxazole
2010
Completed Phase 3
~1260
Nitrofurantoin
2011
Completed Phase 4
~4100
Clindamycin
2017
Completed Phase 4
~14760
Ertapenem
2011
Completed Phase 4
~8070
Levofloxacin
2011
Completed Phase 4
~8180
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
414 Previous Clinical Trials
33,633 Total Patients Enrolled
Khurshid A GuruPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
117 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I choose to have a robot-assisted surgery for bladder removal and can consent.I am a woman who had a fertility-preserving bladder surgery.My kidney function is low, with a creatinine clearance under 30 mL/min.I do not have a history of abnormal heart rhythms nor take medication that affects it.I was given antibiotics before leaving the hospital.I am choosing to have a cystectomy for my bladder cancer.You have a history of myasthenia gravis.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (standard of care)
- Group 2: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.