Nitrofurantoin for Urinary Tract Infection

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

104 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug nitrofurantoin for treating urinary tract infections?

Research shows that nitrofurantoin is effective against common bacteria causing urinary tract infections, like Escherichia coli, and is recommended as a first-line treatment in many guidelines due to its good efficacy and tolerability in short-term use. ^{1 2 3 4 5}

Is nitrofurantoin safe for humans?

Nitrofurantoin is generally considered safe for treating urinary tract infections, but it can cause side effects like lung and liver issues, and in rare cases, serious lung damage. ^{6 7 8 9 10}

How does the drug nitrofurantoin differ from other treatments for urinary tract infections?

Nitrofurantoin is unique because it has been used for over 60 years and remains effective against common bacteria like Escherichia coli, even as resistance to other antibiotics like cotrimoxazole and quinolones has increased. It is recommended as a first-line treatment for uncomplicated urinary tract infections, especially when other antibiotics are less effective or pose more risks. ^{4 5 7 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to learn if the drug Nitrofurantoin (NF) taken as a daily antibiotic, works to treat cystitis compared to electrofulguration (EF) and Nitrofurantoin (NF) daily antibiotic.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Clinical Efficacy of Nitrofurantoin for Treating Uncomplicated Urinary Tract Infection in Adults: A Systematic Review of Randomized Control Trials. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Nitrofurantoin: the return of an old friend in the wake of growing resistance. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Exploring the in situ evolution of nitrofurantoin resistance in clinically derived uropathogenic Escherichia coli isolates. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Influence of flocculating agents and structural vehicles on the physical stability and rheological behavior of nitrofurantoin suspension. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Nitrofurantoin-induced pulmonary fibrosis: a case report. [2021]

7. England 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. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Fatal nitrofurantoin lung. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nightly nitrofurantoin as prophylaxis in dogs with recurrent urinary tract infections: 13 cases (2015-2021). [2023]

10. Switzerland 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. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Nitrofurantoin-induced systemic inflammatory response syndrome. [2013]

12. Canada pubmed.ncbi.nlm.nih.gov

Kidney function and the use of nitrofurantoin to treat urinary tract infections in older women. [2022]