Establish the Relationship Between Shift in Prescribing P... | NCT03716804

Studies
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

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status

Completed

Last Update Posted

Aug 5, 2020Actual

Enrollment

62Actual

Phase

Phase 4

Conditions

Uncomplicated Urinary Tract Infection
Antibiotic Resistant Infection

Interventions

Tablet Nitrofurantoin
Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Oct 17, 2018

First Submission Date that Met QC Criteria

Oct 21, 2018

First Posted Date

Oct 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2020

Last Update Posted Date

Aug 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Sabiha Mahboob, Resident, Phase B, Pharmacology, BSMMU, Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPrincipal Investigator

Lead Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tablet Nitrofurantoin	Drug	Tablet Nitrofurantoin (100 mg), two times daily in 12 hours interval for 7 days	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Md. Sayedur Rahman, MBBS,Mphil,FCPS	Head of the Department, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Combined Military Hosptal, Dhaka		Dhaka			Bangladesh

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Intervention 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.