Establish the Relationship Between Shift in Prescribing Pattern and Associated Shift in Sensitivity Pattern of Causative Microbes in UTI Patients in a Closed Community (UTI)
Primary Purpose
Uncomplicated Urinary Tract Infection, Antibiotic Resistant Infection
Status
Completed
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
Tablet Nitrofurantoin
Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime
Sponsored by
About this trial
This is an interventional health services research trial for Uncomplicated Urinary Tract Infection
Eligibility Criteria
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
Sites / Locations
- Combined Military Hosptal, Dhaka
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control Group
Arm Description
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.
Intervention: To the Patients- Tablet Ciprofloxacin, 500 mg or,Tablet Cefixime 200 mg or,Tablet Cefuroxime 250 mg (According to physician's personal choice).
Outcomes
Primary Outcome Measures
Shift in sensitivity pattern of microorganisms in urinary pathogens
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 Outcome Measures
Non-inferiority of the drug
Clinical outcome of the patients will be measured over Phone interview after completion of antibiotic treatment.
Indicator:Total patients cured after the treatment.
Full Information
NCT ID
NCT03716804
First Posted
October 17, 2018
Last Updated
August 4, 2020
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT03716804
Brief Title
Establish the Relationship Between Shift in Prescribing Pattern and Associated Shift in Sensitivity Pattern of Causative Microbes in UTI Patients in a Closed Community
Acronym
UTI
Official Title
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
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Urinary Tract Infection, Antibiotic Resistant Infection
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Intervention:
To the Patients- Tablet Ciprofloxacin, 500 mg or,Tablet Cefixime 200 mg or,Tablet Cefuroxime 250 mg (According to physician's personal choice).
Intervention Type
Drug
Intervention Name(s)
Tablet Nitrofurantoin
Intervention Description
Tablet Nitrofurantoin (100 mg), two times daily in 12 hours interval for 7 days
Intervention Type
Drug
Intervention Name(s)
Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime
Intervention Description
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
Primary Outcome Measure Information:
Title
Shift in sensitivity pattern of microorganisms in urinary pathogens
Description
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
Time Frame
Upto 6 months
Secondary Outcome Measure Information:
Title
Non-inferiority of the drug
Description
Clinical outcome of the patients will be measured over Phone interview after completion of antibiotic treatment.
Indicator:Total patients cured after the treatment.
Time Frame
7 days after start of the antibiotic therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Md. Sayedur Rahman, MBBS,Mphil,FCPS
Organizational Affiliation
Head of the Department, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Study Chair
Facility Information:
Facility Name
Combined Military Hosptal, Dhaka
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
Learn more about this trial
Establish the Relationship Between Shift in Prescribing Pattern and Associated Shift in Sensitivity Pattern of Causative Microbes in UTI Patients in a Closed Community
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