Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults

Study Overview
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Brief Summary
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The study aims to investigate bacteriological efficacy of a nitrofurantoin formulation given twice daily for seven days in the treatment of adult patients with microbiologically confirmed uncomplicated urinary tract infection. Additional study objectives are to evaluate clinical efficacy as well as safety and tolerability of the nitrofurantoin formulation.

Official Title
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Open Label Study on the Bacteriological and Clinical Efficacy and Safety of a Nitrofurantoin Formulation Given Twice Daily (Bid) for Seven Days in Uncomplicated Urinary Tract Infection in Adults

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: Nitrofurantoin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-pregnant women and men aged above 18 years old presence of ≥ 2 signs or symptoms suggestive of a UTI (dysuria, urinary frequency, urgency, suprapubic pain) with onset 10 days before enrollment asymptomatic patients with available positive urine culture pyuria defined as positive leucocyte esterase (LE) test with any color change after two minutes collection of clean-voided midstream urine sample for culture and susceptibility testing to confirm bacteriuria normal renal function (defined as blood creatinine < 1.4 mg/100 ml) able to take oral medication on an outpatient basis written informed consent before enrollment Exclusion Criteria: suspicion of complicated UTI (presence of fever above 38°C, flank pain, known urologic structural abnormality) or prostatitis negative urine dipslide results (uropathogen < 100000 CFU (colony-forming units)/mL) or presence of nitrofurantoin resistant isolate uropathogens or mixed cultures of more than two isolates symptoms of UTI within the past 4 weeks evidence of predisposing factor to UTI (e.g. calculi, stricture, primary renal disease like polycystic renal diseases and neurogenic bladder) medical history of anaemia, complicated diabetes mellitus, peripheral neuropathy, vitamin B deficiency, renal insufficiency, other significant renal, hepatic or lung diseases medical history of glucose-6-phosphate dehydrogenase deficiency (G6PD) electrolytes disorders pregnant, breast-feeding women or not using medically accepted, effective method of birth control history of nitrofurantoin hypersensitivity use of systemic bacteriological agent within 48 hours before enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrofurantoin<br>Adult patients with a microbiologically confirmed uncomplicated urinary tract infection | Drug: Nitrofurantoin<br>* 100 mg retard capsules to be taken twice daily for seven days<br>* Other names: Uvamin retard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of bacteriological efficacy | Bacteriological efficacy is assessed by number and type of isolates in a clean-void midstream urine sample. | after 12-42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of clinical efficacy | Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain). | after 12-42 days | 
| Evaluation of safety and tolerability | Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events | 1-42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary tract infection, nitrofurantoin