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

Phase 4

Completed

• Conditions: Uncomplicated Urinary Tract Infection; Antibiotic Resistant Infection
• Interventions: Drug: Tablet Nitrofurantoin; Drug: Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime

• Registration Number: NCT03716804
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Study Timeline

• Study Start: 2018-06-06
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-21
• Study First Posted: 2018-10-23
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Tablet Nitrofurantoin	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.
Control Group	Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime	Intervention: To the Patients- Tablet Ciprofloxacin, 500 mg or,Tablet Cefixime 200 mg or,Tablet Cefuroxime 250 mg (According to physician's personal choice).

Primary Outcome Measures

Name	Time	Method
Shift in sensitivity pattern of microorganisms in urinary pathogens	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 Outcome Measures

Name	Time	Method
Non-inferiority of the drug	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.

Trial Locations

Locations (1)

Combined Military Hosptal, Dhaka; 🇧🇩 Dhaka, Bangladesh