Noroxin Efficacy and Safety Trial (NEST)

OBS Pakistan

Status and phase: Unknown; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Norfloxacin 400 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT03506256

OBS-NEST-003

Details and patient eligibility

About

To determine the efficacy and safety of Norfloxacin (Noroxin)

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Norofloxacin

Experimental group

Description:

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.

Treatment:

Drug: Norfloxacin 400 MG