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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking antibiotics for a month can prevent urinary tract infections (UTIs) after bladder removal surgery, known as radical cystectomy. UTIs commonly occur after this surgery, and the trial tests antibiotics such as trimethoprim-sulfamethoxazole, nitrofurantoin, clindamycin, and ertapenem for their effectiveness. Individuals undergoing this surgery due to bladder cancer might be suitable candidates for the trial. The goal is to better predict and manage complications from the surgery. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking drugs that prolong QTc (a heart rhythm measurement), you may be excluded from the trial.

What is the safety track record for these treatments?

Research shows that trimethoprim-sulfamethoxazole, an antibiotic used in this trial, carries some risks. Studies have found it can cause rashes and other side effects. While effective for treating urinary tract infections (UTIs), it may lead to sudden kidney issues or elevated potassium levels in the blood, particularly within the first two weeks of treatment.

Nitrofurantoin, another antibiotic in this trial, is generally well-tolerated. It effectively prevents UTIs compared to no treatment. Side effects are usually mild, but as with any medication, they can occur.

Both antibiotics are commonly used and approved for treating UTIs, indicating they are safe for most people. However, individual reactions can vary, so monitoring for any unusual symptoms is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for urinary tract infections after bladder surgery because they offer alternative options to the standard of care, which typically includes antibiotics like ertapenem, levofloxacin, or clindamycin. The investigational treatments, trimethoprim-sulfamethoxazole and nitrofurantoin, are being tested for their effectiveness and potential benefits in this specific setting. Unlike other options, these antibiotics are known for their targeted action against bacteria commonly responsible for urinary tract infections. This trial may reveal whether these drugs can effectively prevent infections post-surgery, potentially reducing the need for broad-spectrum antibiotics and their associated side effects.

What evidence suggests that these antibiotics are effective for preventing urinary tract infections after bladder surgery?

Research has shown that both trimethoprim-sulfamethoxazole and nitrofurantoin, included in this trial's treatment options, effectively treat urinary tract infections (UTIs). Trimethoprim-sulfamethoxazole significantly lowers the risk of UTIs; one study showed an 85% reduced risk when used for prevention. Nitrofurantoin effectively treats sudden UTIs, with a study showing it cures 84% of cases. Both antibiotics attack the bacteria causing infections. These findings suggest that using these antibiotics can help prevent UTIs after bladder surgery. ^{1 4 5 6 7}

Who Is on the Research Team?

Khurshid A. Guru

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10414118/

Nitrofurantoin: properties and potential in treatment of urinary ... It can be concluded from this review that NF can be considered as the most effective drug in the treatment of acute urinary infection, but due ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03287089?tab=table

Nitrofurantoin Administration for the Prevention of Short ... Although there are a few studies showing favorable results for use of nitrofurantoin during catheterization after pelvic surgery, there are no clearly defined ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK470526/

Nitrofurantoin - StatPearls - NCBI Bookshelf Studies have shown that therapeutic urinary concentrations of the drug are increased by 40% if nitrofurantoin is taken with food. Serum concentrations are ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/413431

Short-Course Nitrofurantoin for the Treatment of Acute ... Results Clinical cure was achieved in 79% of the trimethoprim-sulfamethoxazole group and in 84% of the nitrofurantoin group, for a difference of −5% (95% ...

5. academic.oup.com academic.oup.com/ofid/article/8/9/ofab442/6367630

Retrospective Review on the Safety and Efficacy of ... The purpose of this study was to compare the efficacy and safety of nitrofurantoin for the treatment of cystitis in males and females with variable degrees of ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/nitrofurantoin-oral-route/description/drg-20065102

Nitrofurantoin (oral route) - Side effects & dosage Nitrofurantoin is used to treat urinary tract infections. This medicine is an antibiotic. It works by killing bacteria or preventing their growth.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1198743X16303044

Nitrofurantoin's efficacy and safety as prophylaxis for ... When compared with no prophylaxis, nitrofurantoin is effective in the prevention of UTI (risk ratio 0.38 in favour of nitrofurantoin, 95% CI 0.30–0.48). Its ...