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临床试验/NCT03716804
NCT03716804已完成4 期

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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年6月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Shift in sensitivity pattern of microorganisms in urinary pathogens

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Tablet Nitrofurantoin (Drug)

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).

干预措施: Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime (Drug)

结局指标

主要结局

Shift in sensitivity pattern of microorganisms in urinary pathogens

时间窗: 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

次要结局

  • Non-inferiority of the drug(7 days after start of the antibiotic therapy)

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sabiha Mahboob

Resident, Phase B, Pharmacology, BSMMU

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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