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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Drug: Nitrofurantoin

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14050
    • CIF BIOTEC, Medica Sur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mepha Ltd.
• Investigators: Principal Investigator: Arturo Mendoza Valdes, MD, Cif Biotec, Medical Sur

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (Estimate): March 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 24, 2010
• Last Update Submitted That Met QC Criteria: March 22, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: urinary tract infection; nitrofurantoin
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Anti-Infective Agents; Anti-Bacterial Agents; Anti-Infective Agents, Urinary; Renal Agents; Nitrofurantoin
• Other Study ID Numbers: NIT 001-2006