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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:

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I am a woman who had a fertility-preserving bladder surgery.

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My kidney function is low, with a creatinine clearance under 30 mL/min.

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I do not have a history of abnormal heart rhythms nor take medication that affects it.

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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

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

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 more

Side effects data

From 2014 Phase 3 trial • 607 Patients • NCT00405704

14%

Fever

Rash

Pharyngitis

Viral Infection

Diarrhea

Otitis Media

100%

80%

60%

40%

20%

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

Nitrofurantoin

2011

Completed Phase 4

~4100

Trimethoprim-Sulfamethoxazole

2010