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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01092351
• Date of registration: 15/03/2010
• Prospective Registration: No
• Primary sponsor: Mepha Ltd.
• Public title: Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults
• Scientific title: 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
• Date of first enrolment: January 2007
• Target sample size: 37
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01092351
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Arturo Mendoza Valdes, MD
• Affiliation: Cif Biotec, Medical Sur

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Urinary Tract Infection

Intervention(s)

Drug: Nitrofurantoin

Primary Outcome(s)

Evaluation of bacteriological efficacy [Time Frame: after 12-42 days]

Secondary Outcome(s)

Evaluation of clinical efficacy [Time Frame: after 12-42 days]

Evaluation of safety and tolerability [Time Frame: 1-42 days]

Secondary ID(s)

NIT 001-2006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors