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

Phase 4

Completed

• Conditions: Urinary Tract Infection
• Interventions: Drug: Nitrofurantoin

• Registration Number: NCT01092351
• Lead Sponsor: Mepha Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-22
• Last Update Submitted: 2010-03-22
• Study First Posted: 2010-03-24
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitrofurantoin	Nitrofurantoin	Adult patients with a microbiologically confirmed uncomplicated urinary tract infection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cif Biotec, Medica Sur; 🇲🇽 Mexico City, Mexico