Establish the Relationship Between Shift in Prescribing Pattern and Associated Shift in Sensitivity Pattern of Causative Microbes in UTI Patients in a Closed Community
Condition: Uncomplicated Urinary Tract Infection; Antibiotic Resistant Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      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
    

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.
    

Intervention name(s): Tablet Nitrofurantoin; Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime
Intervention type(s): Drug; Drug
Intervention description(s): Tablet Nitrofurantoin (100 mg), two times daily in 12 hours interval for 7 days; 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
Intervention MeSH terms: Ciprofloxacin; Cefuroxime; Cefuroxime axetil; Nitrofurantoin; Cefixime
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment Intervention group: Educational intervention to prescribers and Medicine-Tab Nitrofurantoin (100 mg, 2 times daily for 7 days) to the patients.
Control group: No educational intervention to the prescribers and Medicine- of personal choice of physician(Tablet Ciprofloxacin, 500 mg/Tablet Cef 3, 200 mg/Tab Cefuroxime, 250 mg) to the patients.
Masking: None (Open Label)
Primary purpose: Health Services Research