Establish the Relationship Between Shift in Prescribing Pattern and Associated Shift in Sensitivity Pattern of Causative Microbes in UTI Patients in a Closed Community

Overview

To establish a relationship between changed prescribing pattern and associated shift in sensitivity trend of causative microbes in patients of uncomplicated urinary tract infection in a closed community

Full Title of Study: “Introduction of Nitrofurantoin in Place of Ciprofloxacin in Patients of Uncomplicated Urinary Tract Infection: a Controlled Clinical Trial to Establish the Relationship Between Revival and Associated Shift in Sensitivity Pattern of the Causative Microbes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

Detailed Description

Antibiotic resistance has become a startling issue in last two decades. Many strategies are being followed to combat antibiotic resistance; revival of older, effective antibiotics is one of those approaches. Urinary tract infection is one of the most common indication for which antibiotics are prescribed. Despite having published guidelines in urinary tract infection, studies show that there is wide variability in prescription. The proposed study is designed to reinforce the guideline among a group of prescribers and evaluate the associated shift in sensitivity pattern of common urinary pathogens. This study will be a double center, controlled clinical trial. In this study, the prescribers in intervention arm will be given educational intervention and in control arm no intervention will be given. When a patient is diagnosed as a case of uncomplicated urinary tract infection clinically in intervention arm, after fulfilling the study criteria the patient will be enrolled in the study. Prescription data will be collected on daily basis and sensitivity data will be collected monthly. Clinical outcome of the patients enrolled in the study will be measured over telephone, after completion of their treatment. Sensitivity pattern will be analysed monthly after collection of sensitivity data from the laboratory affiliated with the hospital. All these data will be compiled and analysed at the end of the study. In control arm, prescription data will be collected fortnightly and sensitivity data will be collected monthly. All these data will be compiled and analysed at the end of the study. After approval from the institutional review board (IRB), enrolled patient will be informed about the intervention and the study.Informed written consent will be taken from all the patients, who will take part in the study willingly. Patient's anonymity will be maintained and will be used for study purpose only.

Interventions

  • Drug: Tablet Nitrofurantoin
    • Tablet Nitrofurantoin (100 mg), two times daily in 12 hours interval for 7 days
  • Drug: Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime
    • Tablet Ciprofloxacin (500 mg), two times daily in 12 hours interval for 7 days or, Tablet Cefixime (200 mg), two times daily in 12 hours interval for 7 days or, Tablet Cefuroxime (250 mg), two times daily in 12 hours interval for 7 days

Arms, Groups and Cohorts

  • Experimental: Intervention group
    • Intervention: To the prescribers- Educational intervention about guideline and present sensitivity trend. To the Patients- Tablet Nitrofurantoin(100 mg), two times daily at 12 hours interval for 7 days.
  • Active Comparator: Control Group
    • Intervention: To the Patients- Tablet Ciprofloxacin, 500 mg or,Tablet Cefixime 200 mg or,Tablet Cefuroxime 250 mg (According to physician’s personal choice).

Clinical Trial Outcome Measures

Primary Measures

  • Shift in sensitivity pattern of microorganisms in urinary pathogens
    • Time Frame: Upto 6 months
    • After shift of prescription from Ciprofloxacin to Nitrofurantoin in patients of UTI, the associated shift in sensitivity pattern of causative microbes will be ruled out by analysing the urine culture-sensitivity data from affiliated pathology lab

Secondary Measures

  • Non-inferiority of the drug
    • Time Frame: 7 days after start of the antibiotic therapy
    • Clinical outcome of the patients will be measured over Phone interview after completion of antibiotic treatment. Indicator:Total patients cured after the treatment.

Participating in This Clinical Trial

Inclusion Criteria

  • Clinically diagnosed uncomplicated urinary tract infection – Patient agreed to participate in the study signing an informed written consent Exclusion Criteria:
  • Known hypersensitivity to Nitrofurantoin – Known Case of Diabetes mellitus, Hypertension, glucose-6-phosphate dehydrogenase deficiency – Suspected complicated or recurrent UTI – Elderly Patients of 65 years or more – Neonates ang pregnant women
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    • Provider of Information About this Clinical Study
      • Principal Investigator: Dr. Sabiha Mahboob, Resident, Phase B, Pharmacology, BSMMU – Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    • Overall Official(s)
      • Md. Sayedur Rahman, MBBS,Mphil,FCPS, Study Chair, Head of the Department, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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