Uncomplicated Urinary Tract InfectionPhase 4UTINCT03716804
Establish the Relationship Between Shift in Prescribing Pattern and Associated Shift in Sensitivity Pattern of Causative Microbes in UTI Patients in a Closed Community
A Phase 4 study testing Tablet Nitrofurantoin and Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime in people with Uncomplicated Urinary Tract Infection and Antibiotic Resistant Infection, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Uncomplicated Urinary Tract Infection, Antibiotic Resistant Infection
- What is being tested?
- Tablet Nitrofurantoin and Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBangladesh
- Study dates
- 6 Jun 2018to 31 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed uncomplicated urinary tract infection
- Patient agreed to participate in the study signing an informed written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Being tested
- Tablet Nitrofurantoin, Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet NitrofurantoinDrug
Tablet Nitrofurantoin (100 mg), two times daily in 12 hours interval for 7 days
Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet CefuroximeDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Upto 6 months
Secondary outcomes (1)
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.
Measured: 7 days after start of the antibiotic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start6 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sabiha Mahboob, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Md. Sayedur Rahman, MBBS,Mphil,FCPS, Study chair, Head of the Department, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716804
- Sponsor's protocol ID
- BSMMU/2018/4643
- Acronym
- UTI
- Status last verified
- Aug 2020
- First submitted
- 17 Oct 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03716804
- Acronym / sponsor ID
- UTI / BSMMU/2018/4643
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Tablet NitrofurantoinIntervention: 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. |
| Control Group | Active comparator | Drug: Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet CefuroximeIntervention: To the Patients- Tablet Ciprofloxacin, 500 mg or,Tablet Cefixime 200 mg or,Tablet Cefuroxime 250 mg (According to physician's personal choice). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed uncomplicated urinary tract infection
- Patient agreed to participate in the study signing an informed written consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet NitrofurantoinTablet Nitrofurantoin (100 mg), two times daily in 12 hours interval for 7 days | Drug | Intervention group |
| Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet CefuroximeTablet 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 | Drug | Control Group |
Primary outcome
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
1 secondary outcome
Non-inferiority of the drug
Time frame: 7 days after start of the antibiotic therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
Related trials for Uncomplicated Urinary Tract Infection
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A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Md. Sayedur Rahman, MBBS,Mphil,FCPS study chair
Head of the Department, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tablet Nitrofurantoin and Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime in people with Uncomplicated Urinary Tract Infection and Antibiotic Resistant Infection, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shift in sensitivity pattern of microorganisms in urinary pathogens (time frame: Upto 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.