Noroxin Efficacy and Safety Trial

Urinary Tract Infections Clinical Trial

— NEST  

Official title:

Noroxin Efficacy and Safety Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03506256
• Other study ID #: OBS-NEST-003
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 1, 2018
• Last updated: April 22, 2018
• Start date: May 10, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: April 2018
• Source: OBS Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy and safety of Norfloxacin (Noroxin)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 30, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OBS Pakistan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients treated with Noroxin (Efficacy)	To evaluate efficacy of Norfloxacin by measuring clinical response, the resolution of sign and symptoms of post-therapy as compared to start of therapy	14 Days
Secondary	Number of Adverse Effects with Noroxin (Safety)	To determine number of patients that experienced Adverse effects	14 Days