NCT03506256

Noroxin Efficacy and Safety Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: OBS Pakistan · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Norfloxacin 400 MG	Norfloxacin is an oral fluoroquinolone antimicrobial agent used for the treatment of uncomplicated and complicated urinary tract infections. The drug antagonizes DNA gyrase, an enzyme essential for bacterial DNA replication and is active in vitro against virtually all bacterial pathogens causing urinary tract8

Timeline

• Start date: 2018-05-10
• Primary completion: 2018-06-10
• Completion: 2018-07-30
• First posted: 2018-04-24
• Last updated: 2018-04-24