Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults
NCT ID: NCT01092351
Last Updated: 2010-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
37 participants
INTERVENTIONAL
2007-01-31
2008-09-30
Brief Summary
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Additional study objectives are to evaluate clinical efficacy as well as safety and tolerability of the nitrofurantoin formulation.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nitrofurantoin
Adult patients with a microbiologically confirmed uncomplicated urinary tract infection
Nitrofurantoin
100 mg retard capsules to be taken twice daily for seven days
Interventions
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Nitrofurantoin
100 mg retard capsules to be taken twice daily for seven days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mepha Ltd.
INDUSTRY
Responsible Party
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Mepha Ltd.
Principal Investigators
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Arturo Mendoza Valdes, MD
Role: PRINCIPAL_INVESTIGATOR
Cif Biotec, Medical Sur
Locations
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Cif Biotec, Medica Sur
Mexico City, , Mexico
Countries
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Other Identifiers
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NIT 001-2006
Identifier Type: -
Identifier Source: org_study_id
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