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

NCT ID: NCT03716804

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-06
• Study Completion Date: 2019-01-31

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.

Conditions

Uncomplicated Urinary Tract Infection; Antibiotic Resistant Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tablet Nitrofurantoin

Intervention Type: DRUG

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

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).

Group Type: ACTIVE_COMPARATOR

Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime

Intervention Type: DRUG

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

Interventions

Tablet Nitrofurantoin

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sabiha Mahboob

Resident, Phase B, Pharmacology, BSMMU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Md. Sayedur Rahman, MBBS,Mphil,FCPS

Role: STUDY_CHAIR

Head of the Department, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Combined Military Hosptal, Dhaka

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

BSMMU/2018/4643

Identifier Type: -

Identifier Source: org_study_id