Antibiotics for Urinary Tract Infections After Bladder Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Roswell Park Cancer Institute

Must not be taking: QT prolonging drugs

Disqualifiers: Myasthenia gravis, Renal dysfunction, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

89 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Khurshid A. Guru

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I choose to have a robot-assisted surgery for bladder removal and can 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

I am choosing to have a cystectomy for my bladder cancer.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prophylactic antibiotics or standard care post-surgery

4 weeks

Daily monitoring through drug diary

Follow-up

Participants are monitored for safety and effectiveness after treatment

120 days

Treatment Details

Interventions

• Clindamycin
• Diary
• Ertapenem
• Levofloxacin
• Nitrofurantoin
• Trimethoprim-Sulfamethoxazole

Trial Overview 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.

Participant Groups

Group I: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) Experimental Treatment 6 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 Control 3 Interventions

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

Clindamycin is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Cleocin for:

• Serious bacterial infections
• Anaerobic bacterial infections
• Streptococcal infections
• Staphylococcal infections
• Pneumococcal infections

Approved in European Union as Dalacin for:

• Serious bacterial infections
• Anaerobic bacterial infections
• Streptococcal infections
• Staphylococcal infections
• Pneumococcal infections

Approved in Canada as Cleocin for:

• Serious bacterial infections
• Anaerobic bacterial infections
• Streptococcal infections
• Staphylococcal infections
• Pneumococcal infections

Approved in Japan as Clindamycin for:

• Serious bacterial infections
• Anaerobic bacterial infections
• Streptococcal infections
• Staphylococcal infections
• Pneumococcal infections

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+