Noroxin Efficacy and Safety Trial

NCT03506256 | Unknown Phase 4

• 1 other identifier: OBS-NEST-003
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the efficacy and safety of Norfloxacin (Noroxin)

Conditions

Urinary Tract Infections

Keywords

urinary tract infection; Norfloxacin; Fluroquinolone; Safety; Pakistan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Adverse Effects with Noroxin (Safety)

  14 Days

Study Arms (1)

Norofloxacin

EXPERIMENTAL

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

Interventions

Norfloxacin 400 MG DRUG

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

Norofloxacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OBS Pakistan: lead

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Norfloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2018
• First Posted: April 24, 2018
• Study Start: May 10, 2018
• Primary Completion: June 10, 2018
• Study Completion: July 30, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share