NCT01092351CompletedPhase 4
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
Mepha Ltd.1 site in 1 country37 target enrollmentStarted: January 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Evaluation of bacteriological efficacy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nitrofurantoin
Experimental
Adult patients with a microbiologically confirmed uncomplicated urinary tract infection
Intervention: Nitrofurantoin (Drug)
Outcomes
Primary Outcomes
Evaluation of bacteriological efficacy
Time Frame: after 12-42 days
Bacteriological efficacy is assessed by number and type of isolates in a clean-void midstream urine sample.
Secondary Outcomes
- Evaluation of clinical efficacy(after 12-42 days)
- Evaluation of safety and tolerability(1-42 days)
Investigators
Study Sites (1)
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