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

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ClinicalTrials.gov Identifier: NCT03716804
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Sabiha Mahboob, 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

Condition or disease Intervention/treatment Phase
Uncomplicated Urinary Tract Infection Antibiotic Resistant Infection Drug: Tablet Nitrofurantoin Drug: Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 25, 2019


Arm Intervention/treatment
Experimental: 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.

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

Active Comparator: 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).

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




Primary Outcome Measures :
  1. Shift in sensitivity pattern of microorganisms in urinary pathogens [ Time Frame: 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 :
  1. Non-inferiority of the drug [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716804


Contacts
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Contact: Sabiha Mahboob, MBBS 1769667107 ext +880 shabnamashik1213@gmail.com
Contact: Md. Sayedur Rahman, MBBS,Mphil,FCPS 1971840757 ext +880 srkhasru@gmail.com

Locations
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Bangladesh
Combined Military Hosptal, Dhaka Recruiting
Dhaka, Bangladesh
Contact: Abdul Quddus Bhuiyan, MBBS, FCPS    1673615641 ext +880      
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Study Chair: Md. Sayedur Rahman, MBBS,Mphil,FCPS Head of the Department, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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Responsible Party: Dr. Sabiha Mahboob, Resident, Phase B, Pharmacology, BSMMU, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03716804    
Other Study ID Numbers: BSMMU/2018/4643
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Ciprofloxacin
Cefuroxime
Cefuroxime axetil
Nitrofurantoin
Cefixime
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents