Clinical trial NCT01092351: Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infection
Keywords: urinary tract infection
nitrofurantoin
Lead sponsor: Mepha Ltd.
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Evaluation of bacteriological efficacy
timeFrame: after 12-42 days
Secondary outcomes:
measure: Evaluation of clinical efficacy
timeFrame: after 12-42 days
measure: Evaluation of safety and tolerability
timeFrame: 1-42 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Cif Biotec, Medica Sur
Study officials:
affiliation: Cif Biotec, Medical Sur
name: Arturo Mendoza Valdes, MD
role: PRINCIPAL_INVESTIGATOR
References: