Nitrofurantoin for Urinary Tract Infection

Not yet recruiting at 1 trial location

Overseen By Meghan Leak

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Antibiotics, Uromune, Phage therapy

Disqualifiers: Complicated UTIs, Uncontrolled diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the daily antibiotic Nitrofurantoin effectively treats recurrent urinary tract infections (UTIs), specifically cystitis. Researchers aim to compare this treatment to a combination of Nitrofurantoin and electrofulguration, a procedure using heat to treat the bladder. Women who have experienced at least three UTIs in the past year or two in the past six months and are currently symptom-free may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking research.

Will I have to stop taking my current medications?

If you are currently taking antibiotics, you will need to stop them to participate in this trial. The trial excludes patients on antibiotics at the start, those on self-start therapy, and those on prophylactic antibiotics started in the last 3 months unless they are willing to discontinue.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that nitrofurantoin has a low rate of serious side effects, with severe side effects reported in only 0.02 to 1.5 out of every 1,000 users. This indicates that the drug is generally well-tolerated for treating urinary tract infections (UTIs). Its safety for this condition is well-established, as nitrofurantoin is already in use for UTIs.

Research on electrofulguration, a procedure sometimes used for recurring UTIs, has demonstrated its safety for many patients. Most people experience a cure or improvement with this treatment.

Both nitrofurantoin and electrofulguration have shown good safety records in studies, providing reassurance about their use in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore a potentially enhanced approach to managing urinary tract infections (UTIs) with nitrofurantoin. Unlike other UTI treatments that often involve short courses of antibiotics, this approach includes a daily antibiotic prophylaxis, which may offer sustained protection over six months. Additionally, the experimental arm combines this regimen with electrofulguration (EF), a technique aiming to improve outcomes by directly targeting and destroying problematic tissues. This combination could provide a more comprehensive solution to preventing recurrent UTIs, potentially offering better long-term effectiveness compared to standard antibiotic treatments alone.

What evidence suggests that this trial's treatments could be effective for cystitis?

Research has shown that nitrofurantoin, which participants in this trial may receive, effectively treats urinary tract infections (UTIs), with studies finding cure rates between 79% and 92%. Regular use of nitrofurantoin also significantly reduces the risk of UTIs. Another treatment option in this trial combines nitrofurantoin with electrofulguration, a method using electricity to destroy tissue. This combination has shown promise, with many patients experiencing no recurrence of infections. Together, these treatments may offer a strong defense against UTIs. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for women aged 18-85 with a history of recurrent UTIs, who are likely to stay in the study area and have no major health issues like severe allergies to Nitrofurantoin, pregnancy, psychosis, uncontrolled diabetes, or chronic kidney problems. They should not be on antibiotics at the start or have conditions like neurogenic bladder.

Inclusion Criteria

Likely to stay in the geographic region for the duration of the study

ASA class II or less

I am a woman aged 18-85 with a history of UTIs proven by tests.

Exclusion Criteria

Allergy or resistance to Nitrofurantoin

Pregnancy

I am currently taking antibiotics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Nitrofurantoin daily antibiotic prophylaxis alone or Nitrofurantoin plus electrofulguration for 6 months

6 months

8 visits (in-person) throughout the study

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of UTI episodes and quality of life

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Electrofulguration
• Nitrofurantoin

Trial Overview The study compares daily use of Nitrofurantoin (an antibiotic) alone versus combining it with electrofulguration (a procedure that uses electric current to treat tissue) in treating cystitis in women with frequent urinary tract infections.

How Is the Trial Designed?

Group I: Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF) Experimental Treatment 2 Interventions

Group II: Nitrofurantoin (NF) daily antibiotic prophylaxis Active Control 1 Intervention

Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Nitrofurantoin is effective in preventing urinary tract infections (UTIs), showing a significant reduction in risk compared to no prophylaxis, with a risk ratio of 0.38 based on a systematic review of 26 controlled trials involving 3052 patients.

While nitrofurantoin is generally safe, it is associated with a higher risk of non-severe adverse effects compared to other antibacterials, although severe adverse effects are rare, occurring in only 0.02-1.5 per 1000 users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrofurantoin's efficacy and safety as prophylaxis for urinary tract infections: a systematic review of the literature and meta-analysis of controlled trials. Muller, AE., Verhaegh, EM., Harbarth, S., et al.[2022]

Long-term use of nitrofurantoin, a common treatment for urinary tract infections, may lead to severe pulmonary complications, as demonstrated in a case of a 51-year-old woman who developed lung fibrosis after years of treatment.

The autopsy findings indicated that the lung fibrosis was likely induced by nitrofurantoin, highlighting the need for regular monitoring of patients on this medication for potential adverse pulmonary effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrofurantoin-induced pulmonary fibrosis: a case report. Goemaere, NN., Grijm, K., van Hal, PT., et al.[2021]

Nitrofurantoin is a broad-spectrum antibiotic effective against both Gram-negative and Gram-positive bacteria, making it a valuable option for treating acute lower urinary tract infections, especially in the context of rising antibiotic resistance.

Recent data suggest that nitrofurantoin is particularly useful for managing urinary tract infections caused by multidrug-resistant pathogens, highlighting its importance as a treatment option when other oral antibiotics are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Old Antibiotics in the Era of Antibiotic Resistance. Highlighted Nitrofurantoin for the Treatment of Lower Urinary Tract Infections. Munoz-Davila, MJ.[2020]

In a study of 13 dogs receiving nightly nitrofurantoin for recurrent urinary tract infections, the treatment was well tolerated and resulted in a median infection-free interval of 268 days, with eight dogs showing no positive urine cultures during therapy.

However, treatment failures were noted, particularly due to infections with nitrofurantoin-resistant Proteus spp., highlighting the need for monitoring and potential adjustments in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nightly nitrofurantoin as prophylaxis in dogs with recurrent urinary tract infections: 13 cases (2015-2021). Murray, O., Furrow, E., Granick, J., et al.[2023]

Nitrofurantoin remains an effective treatment for uncomplicated urinary tract infections (UTIs), particularly against common pathogens like E. coli, despite its long history of use and potential side effects.

Recent studies indicate that short-term nitrofurantoin therapy is well-tolerated and effective, making it a recommended first-line treatment in current guidelines, although it is contraindicated in late pregnancy and for patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nitrofurantoin--clinical relevance in uncomplicated urinary tract infections]. Stock, I.[2014]

The study identified that a nitrofurantoin suspension with glycerin (0.2%) and sodium citrate (0.3%) significantly improved physical stability, making it a promising formulation for treating urinary tract infections.

The optimal formulation, which included Veegum (1%), sodium carboxyl methyl cellulose (1%), glycerin, sodium citrate, and sorbitol (20%), exhibited pseudoplastic behavior, indicating good flow properties and ease of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of flocculating agents and structural vehicles on the physical stability and rheological behavior of nitrofurantoin suspension. Moghimipour, E., Salimi, A., Rezaee, S., et al.[2022]

Citations

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

Nitrofurantoin: properties and potential in treatment of urinary ... NF was determined to be clinically and microbiologically effective, with clinical cure rates between 79% to 92% and microbiological eradication ...

2. 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 ...

3. 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 ...

4. 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00678041?term=NITROFURANTOIN&viewType=Table&rank=10

Nitrofurantoin and Urinary Tract Infections (UTIs) Data Analysis: Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test. Sample Size: Assuming a decrease in symptomatic UTIs ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37384844/

Very Long-term Outcomes After Electrofulguration for ... Primary outcome was clinical cure (0-1 urinary tract infection/y), improvement (>1 and <3/y) or failure (≥3/y) at last follow-up. Secondary ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S009042952031027X

Favorable Outcomes of Repeat Electrofulguration ... Of 24 women who underwent a third electrofulguration, 11/24 (46%) were clinically successful or improved at median 22 months follow-up. Urine cultures from the ...

8. auajournals.org auajournals.org/doi/pdf/10.1097/JU.0000000000003612

fiterm Outcomes After Electrofulguration for Antibiotic- ... Primary outcome was clinical cure (0-1 urinary tract infection/y), improvement. (>1 and <3/y) or failure ( 3/y) at last follow-up. Secondary outcomes included.

9. journals.asm.org journals.asm.org/doi/10.1128/spectrum.04311-23

Bacterial species cultured after electrofulguration in women ... Confirming prior studies, we found that fulguration in women with antibiotic-recalcitrant recurrent urinary tract infections and cystitis ...

10. karger.com karger.com/uin/article/doi/10.1159/000543733/920188/Efficacy-of-Electrofulguration-for-Women-with

Efficacy of Electrofulguration for Women with Recurrent ... The results showed that EF is safe procedure, which resulted in clinical cure and improvement in the large majority of the patients. A ...