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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01092351

Enrollment

Registered

2010-03-24

Start date

2007-01-31

Completion date

2008-09-30

Last updated

2010-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection

Keywords

urinary tract infection, nitrofurantoin

Brief summary

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.

Interventions

DRUGNitrofurantoin

100 mg retard capsules to be taken twice daily for seven days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026