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

Antibiotic Resistant Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716804
• Other study ID #: BSMMU/2018/4643
• Status: Completed
• Phase: Phase 4
• Start date: June 6, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2020
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Communicable Diseases
• Infection
• Uncomplicated Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Tablet Nitrofurantoin
Tablet Nitrofurantoin (100 mg), two times daily in 12 hours interval for 7 days
• 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

Locations

Country	Name	City	State
Bangladesh	Combined Military Hosptal, Dhaka	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Upto 6 months
Secondary	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.	7 days after start of the antibiotic therapy