Noroxin Efficacy and Safety Trial
Noroxin Efficacy and Safety Trial
To determine the efficacy and safety of Norfloxacin (Noroxin)
Urinary tract infections (UTIs) are some of the most common bacterial infections, affecting
 150 million people each year worldwide. Clinically, UTIs are categorized as uncomplicated or
 complicated. Uncomplicated UTIs typically affect individuals who are otherwise healthy and
 have no structural or neurological urinary tract abnormalities; these infections are
 differentiated into lower UTIs (cystitis) and upper UTIs (pyelonephritis). Several risk
 factors are associated with cystitis, including female gender, a prior UTI, sexual activity,
 vaginal infection, diabetes, obesity and genetic susceptibility.

 UTIs are caused by both Gram-negative and Gram-positive bacteria, as well as by certain
 fungi. The most common causative agent for both uncomplicated and complicated UTIs is
 uropathogenic Escherichia coli (UPEC). For the agents involved in uncomplicated UTIs, UPEC is
 followed in prevalence by Klebsiella pneumoniae, Staphylococcus saprophyticus, Enterococcus
 faecalis, group B Streptococcus (GBS), Proteus mirabilis, Pseudomonas aeruginosa,
 Staphylococcus aureus and Candida spp. Currently, antibiotics - such as trimethoprim
 sulfamethoxazole, floxacin and ampicillin - are the most commonly recommended therapeutics
 for UTIs6. UTIs are becoming increasingly difficult to treat owing to the widespread
 emergence of an array of antibiotic resistance mechanisms. Of particular concern are members
 of the family Enterobacteriaceae, including E. coli and K. pneumoniae, which have both
 acquired plasmids encoding extended-spectrum β-lactamases (ESBLs). These plasmids rapidly
 spread resistance to third-generation cephalosporins as well as other antibiotics.
Inclusion Criteria:

 -  Written informed consent

 -  At least one typical symptom of acute, lower urinary tract infection out of dysuria,
 frequency, macrohaematuria, cloudy or smelly urine or self-diagnosed cystitis

 Exclusion Criteria:

 -  Duration of UTI symptoms for more than 7 days before physician's visit

 -  Clinical signs of invasiveness such as fever (axillary body temperature >38 degrees
 Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting

 -  Known or suspicion of anatomical or functional abnormality of the urinary tract

 -  Vaginal symptoms: discharge, irritation

 -  Diabetes mellitus

 -  Immunosuppression (e.g. prednisone equivalent >10mg per day for >14 days,
 chemotherapy, radiotherapy, immunomodulators, HIV infection, neutropenia)

 -  Any other serious comorbidity as judged by the treating physician

 -  Bladder catheter in situ or during the past 30 days

 -  Pregnancy

 -  Recurrent urinary tract infection (more than 3 infections during the last 12 months)

 -  Antibiotic treatment during the last 4 weeks