Noroxin Efficacy and Safety Trial (NEST)
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|ClinicalTrials.gov Identifier: NCT03506256|
Recruitment Status : Not yet recruiting
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Drug: Norfloxacin 400 MG||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Noroxin Efficacy and Safety Trial|
|Estimated Study Start Date :||May 10, 2018|
|Estimated Primary Completion Date :||June 10, 2018|
|Estimated Study Completion Date :||July 30, 2018|
The recommended dosage of norfloxacin for urinary-tract infections in adults is 400 mg orally every 12 hours; the drug should be given for 7 to 10 days in uncomplicated infections and for 10 to 21 days in complicated ones. Adverse drug effects were mild and included disturbances of the gastrointestinal tract and the central nervous system. The study shall be completed in accordance with the ICH topic E6 (R1)(CPMP/ICH/one hundred thirty five/95) guiding principle for top medical practice and the ideas enunciated within the announcement of Helsinki and the approval by way of an Institutional Ethics Committee.
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
- Number of Patients treated with Noroxin (Efficacy) [ Time Frame: 14 Days ]To evaluate efficacy of Norfloxacin by measuring clinical response, the resolution of sign and symptoms of post-therapy as compared to start of therapy
- Number of Adverse Effects with Noroxin (Safety) [ Time Frame: 14 Days ]To determine number of patients that experienced Adverse effects