Prophylactic Antibiotics for Bladder Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Minnesota
Must not be taking: Antimicrobials
Disqualifiers: Poor renal function, Allergy, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are currently receiving antimicrobials for an active infection, you would not be eligible to participate.
Is nitrofurantoin safe for humans?
How does the drug nitrofurantoin differ from other treatments for bladder cancer?
Eligibility Criteria
This trial is for individuals with muscle invasive bladder cancer who are undergoing radical cystectomy and urinary diversion. Specific eligibility details aren't provided, but typically participants must meet certain health criteria to join.Inclusion Criteria
I am 18 years old or older.
I have bladder cancer and will have surgery to remove my bladder.
Exclusion Criteria
Pregnancy
Unable to provide Informed consent
I am currently on medication for an infection.
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo radical cystectomy with urinary diversion and are randomized to receive either no prophylactic antibiotics or prophylactic oral antibiotic, nitrofurantoin, postoperatively
Immediate postoperative period
Follow-up
Participants are monitored for postoperative urinary tract infections and other outcomes
90 days
Treatment Details
Interventions
- Nitrofurantoin (Anti-infective Agent)
Trial OverviewThe study compares the effect of not using prophylactic antibiotics to taking a specific antibiotic (nitrofurantoin) after surgery, by looking at urinary tract infection rates within 90 days post-operation.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment groupExperimental Treatment1 Intervention
Prophylactic antibiotics postoperatively.
Group II: Control groupActive Control1 Intervention
No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Safety and efficacy of nightly nitrofurantoin as prophylaxis in dogs with recurrent urinary tract infections: 13 cases (2015-2021). [2023]To report the protocol, efficacy and adverse events in dogs receiving nightly nitrofurantoin therapy as antimicrobial prophylaxis for recurrent urinary tract infections.
[Pulmonary fibrosis secondary to nitrofurantoin]. [2013]We report a case of pulmonary fibrosis from long-term furantoin therapy after radical surgery for a bladder tumor and urinary intestinal diversion. The patient developed pulmonary superinfection and acute respiratory failure. She initially responded to treatment, but relapsed two weeks later. The underlying pathological condition led to the patient's death.
Nitrofurantoin-induced pulmonary fibrosis: a case report. [2021]Nitrofurantoin is a commonly used drug in the treatment and prevention of urinary tract infections. Many adverse effects of nitrofurantoin have been documented, including aplastic anemia, polyneuritis, and liver and pulmonary toxicity.
[Pulmonary fibrosis secondary to nitrofurantoin]. [2013]Herein we report a case of pulmonary fibrosis secondary to chronic administration of nitrofurantoin following radical surgery for a bladder tumor and urinary intestinal diversion. The patient developed pulmonary superinfection and acute respiratory failure. She initially responded to treatment, but relapsed after two weeks. She died from the underlying disease.
Role of Old Antibiotics in the Era of Antibiotic Resistance. Highlighted Nitrofurantoin for the Treatment of Lower Urinary Tract Infections. [2020]Bacterial infections caused by antibiotic-resistant isolates have become a major health problem in recent years, since they are very difficult to treat, leading to an increase in morbidity and mortality. Nitrofurantoin is a broad-spectrum bactericidal antibiotic that, through a complex mode of action which is not completely understood, affects both Gram-negative and Gram-positive bacteria. Nitrofurantoin has been used successfully for a long time for the prophylaxis and treatment of acute lower urinary tract infections in adults, children and pregnant women, but the increased emergence of antibiotic resistance has made nitrofurantoin a suitable candidate for the treatment of infections caused by multidrug-resistant pathogens. Here, we review the mechanism of action, antimicrobial spectrum, pharmacology and safety profile of nitrofurantoin. We also investigate the therapeutic use of nitrofurantoin, including recent data which highlight its role in the management of community urinary tract infection, especially in cases of multidrug-resistant isolates, in which oral active antimicrobials are limited resources nowadays.
Influence of flocculating agents and structural vehicles on the physical stability and rheological behavior of nitrofurantoin suspension. [2022]Nitrofurantoin is a nitrofuran antibiotic that has been used for treatment of urinary tract against positive and negative bacteria.
[Nitrofurantoin--clinical relevance in uncomplicated urinary tract infections]. [2014]The nitrofuran derivative nitrofurantoin has been used for more than 60 years for the antibacterial therapy of uncomplicated urinary tract infections (UTI). Despite its long application, this antibiotic retained good activity against Escherichia coli and some other pathogens of uncomplicated urinary tract infections such as Staphylococcus saprophyticus and Enterococcus species. Nitrofurantoin therapy has been shown to be accompanied by numerous adverse drug effects. Among these, there are also serious side effects such as pulmonary reactions and polyneuropathy, which mainly occur in long-term use. Recent studies, however, have shown a good efficacy and tolerability of short-term nitrofurantoin therapy comparable to previous established standard therapeutic regimens applying cotrimoxazole or quinolones. Because of these data and the alarming resistance rates of uropathogenic Escherichia coli to cotrimoxazole and quinolones that have been increased markedly in several countries, the clinical significance ofnitrofurantoin has been raised again. In many current treatment guidelines, e. g., the international clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women published by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases, nitrofurantoin has been recommended as one first-line antibiotic of empiric antibacterial treatment of uncomplicated cystitis in otherwise healthy women. In Germany, however, nitrofurantoin should only be applied if more effective and less risky antibiotics cannot be used. Nitrofurantoin is contraindicated in the last three months of pregnancy and in patients suffering from renal impairment of each degree. Despite compatibility concerns, nitrofurantoin has also been recommended for the re-infection prophylaxis of recurrent uncomplicated urinary tract infections in Germany and several other countries.
A comparative drug study of lower urinary tract infections in elderly patients. [2019]The urinary antibacterial drugs cinoxacin (Cinobac) and nitrofurantoin (Macrodantin) were compared for efficacy and side effects in the treatment of uncomplicated lower urinary tract infections occurring in elderly patients admitted to a rehabilitation hospital. Twenty-five patients received cinoxacin and 27 received nitrofurantoin for an average of thirteen days' treatment. The antibacterial spectrum of cinoxacin was noted to be better than that of nitrofurantoin, but both drugs performed well in clearing the infections caused by susceptible organisms. There were no side effects from cinoxacin therapy, but 15 per cent of patients receiving the nitrofurantoin experienced anorexia and nausea, in some cases sufficiently severe to require early termination of therapy.
Nitrofurantoin failure in males with an uncomplicated urinary tract infection: a primary care observational cohort study. [2023]Nitrofurantoin is the first-choice antibiotic treatment for uncomplicated urinary tract infections (UTIs) in males according to the Dutch primary care UTI guideline. However, prostate involvement may be undetected and renders this treatment less suitable.
[Treatment of acute urinary tract infection with a nitrofurantoin-sulphadiazine compound preparation (author's transl)]. [2013]Between september 1978 and april 1979 in 65 hospitalized patients at a medical department an acute urinary tract infection was detected in addition to the primary illness. All patients received as antibacterial treatment a 1 : 3 nitrofurantoin/sulphadiazine compound preparation (Urospasmon cum phenazopyridino), with a daily dose of 150 mg nitrofurantoin + 450 mg sulphadiazin. Therapeutic results and side effects are discussed. Special notice is paid to the iatrogenic infections and the necessity of thorough observation to keep this additional risk for the mostly badly ill patients under control.