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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
Sponsor:
Information provided by (Responsible Party):
OBS Pakistan

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

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: Norfloxacin 400 MG Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Norofloxacin
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Adverse Effects with Noroxin (Safety) [ Time Frame: 14 Days ]
    To determine number of patients that experienced Adverse effects



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: OBS Pakistan
ClinicalTrials.gov Identifier: NCT03506256     History of Changes
Other Study ID Numbers: OBS-NEST-003
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by OBS Pakistan:
urinary tract infection
Norfloxacin
Fluroquinolone
Safety
Pakistan

Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases
Norfloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors