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

Condition(s) targeted: Urinary Tract Infection

Intervention: Nitrofurantoin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mepha Ltd.

Official(s) and/or principal investigator(s):
Arturo Mendoza Valdes, MD, Principal Investigator, Affiliation: Cif Biotec, Medical Sur

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: 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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluation of bacteriological efficacy

Secondary outcome:

Evaluation of clinical efficacy

Evaluation of safety and tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Cif Biotec, Medica Sur, Mexico City 14050, Mexico

Starting date: January 2007
Last updated: March 22, 2010