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

NCT03716804 | Completed Phase 4

• 1 other identifier: BSMMU/2018/4643
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Uncomplicated Urinary Tract Infection; Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Non-inferiority of the drug

  7 days after start of the antibiotic therapy

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Drug: Tablet Nitrofurantoin

Control Group

ACTIVE COMPARATOR

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

Drug: Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime

Interventions

Tablet Nitrofurantoin DRUG

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

Intervention group

Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime 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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed uncomplicated urinary tract infection
• Patient agreed to participate in the study signing an informed written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Combined Military Hosptal, Dhaka

Dhaka, Bangladesh

Location

Study Officials

• Md. Sayedur Rahman, MBBS,Mphil,FCPS

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Phase B, Pharmacology, BSMMU

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 23, 2018
• Study Start: June 6, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

BA (1)