Clinical trial NCT03506256: Noroxin Efficacy and Safety Trial
Official title: Noroxin Efficacy and Safety Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: urinary tract infection
Norfloxacin
Fluroquinolone
Safety
Pakistan
Lead sponsor: OBS Pakistan
Sponsor class: INDUSTRY
First posted: 2018-04-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of Norfloxacin (Noroxin)

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients treated with Noroxin (Efficacy)
timeFrame: 14 Days
Secondary outcomes:
measure: Number of Adverse Effects with Noroxin (Safety)
timeFrame: 14 Days
Other outcomes:
Locations:
Study officials:
References: