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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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|
Experimental: Intervention group
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
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
- 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
- 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.
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
|Contact: Sabiha Mahboob, MBBS||1769667107 ext +email@example.com|
|Contact: Md. Sayedur Rahman, MBBS,Mphil,FCPS||1971840757 ext +firstname.lastname@example.org|
|Combined Military Hosptal, Dhaka||Recruiting|
|Contact: Abdul Quddus Bhuiyan, MBBS, FCPS 1673615641 ext +880|
|Study Chair:||Md. Sayedur Rahman, MBBS,Mphil,FCPS||Head of the Department, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh|