Urinary Tract Infections (UTIs)NCT02305342
Sensitivity of Antibiotics for Urinary Tract Infections Patients Attending Family Physicians
An observational study of Urinary Tract Infections (UTIs), run by Abbott at 1 site in Pakistan.
Trial summary
This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary objective is to study the spectrum of uropathogens responsible for community acquired UTI in local population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections (UTIs)
- How many people
- 350 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2014to Feb 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinics
Who may be able to join
- Samples from primary care clinics from patients who reports UTI symptoms and in which uropathogens are isolated will be included.
Who cannot join
- Samples from specialized, hospitalized or catheterized patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Susceptibility of Bacterial Uro-Pathogens In Patients Attending Family Physicians" (In Vitro Study)
This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary objective is to study the spectrum of uropathogens responsible for community acquired UTI in local population
Read the detailed description
Mid stream , clean catch urine specimens of patients with uncomplicated community acquired UTI sent to microbiology labs by treating consultants from filter clinics for evaluation of pathogens will be utilized for sensitivity analysis.
Only the first positive urine culture obtained per sample will be included in the analysis to eliminate any possibility of recurrence and nosocomial infection. The polymicrobial cultures and cultures with multidrug-resistant uropathogens will not be included in the analysis. Cultures with common contaminants, including coagulase-negative staphylococci and hemolytic streptococci, and cultures with Candida growth will be excluded. .
Data points to be collected will be date of collection, computer generated Lab #, age, gender,list of cultured organisms, sensitivity of organisms with antibiotics.
- Conditions
- Urinary Tract Infections (UTIs)
- Keywords
- Uncomplicated UTI, Enoxacin
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urinary Tract Infections (UTIs) | Uncomplicated UTIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Uropathogens
Sensitivity of identified organisms shall be noted by the zone size in millimeters of the cultured organisms. "Sensitive", "Intermediate" and "Resistant" labels shall be used as per Clinical Laboratory Standard Institute (CLSI) guidelines.
Measured: 3 months
Secondary outcomes (1)
Common UTI pathogens
To enlist the number and names of identified uropathogens from urine cultures.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections (UTIs)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raeefuddin Ahmed, MBBS, FCPS, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305342
- Sponsor's protocol ID
- ENOX5001
- Status last verified
- Mar 2015
- First submitted
- 17 Nov 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Susceptibility of Bacterial Uro-Pathogens In Patients Attending Family Physicians" (In Vitro Study)
- ClinicalTrials.gov ID
- NCT02305342
- Acronym / sponsor ID
- ENOX5001
- Conditions
- Urinary Tract Infections (UTIs)
- Keywords
- Uncomplicated UTI, Enoxacin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Dec 2014 (estimated)
- 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.
This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary objective is to study the spectrum of uropathogens responsible for community acquired UTI in local population
Detailed description
Mid stream , clean catch urine specimens of patients with uncomplicated community acquired UTI sent to microbiology labs by treating consultants from filter clinics for evaluation of pathogens will be utilized for sensitivity analysis.
Only the first positive urine culture obtained per sample will be included in the analysis to eliminate any possibility of recurrence and nosocomial infection. The polymicrobial cultures and cultures with multidrug-resistant uropathogens will not be included in the analysis. Cultures with common contaminants, including coagulase-negative staphylococci and hemolytic streptococci, and cultures with Candida growth will be excluded. .
Data points to be collected will be date of collection, computer generated Lab #, age, gender,list of cultured organisms, sensitivity of organisms with antibiotics.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urinary Tract Infections (UTIs) | – | –Uncomplicated UTIs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinics
Key inclusion criteria (1 listed)
- Samples from primary care clinics from patients who reports UTI symptoms and in which uropathogens are isolated will be included.
Key exclusion criteria (1 listed)
- Samples from specialized, hospitalized or catheterized patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of Uropathogens
Time frame: 3 months
Sensitivity of identified organisms shall be noted by the zone size in millimeters of the cultured organisms. "Sensitive", "Intermediate" and "Resistant" labels shall be used as per Clinical Laboratory Standard Institute (CLSI) guidelines.
1 secondary outcome
Common UTI pathogens
Time frame: 3 months
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 6 Mar 2015.
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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.
Raeefuddin Ahmed, MBBS, FCPS study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections (UTIs), run by Abbott at 1 site in Pakistan.
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 1 inclusion and 1 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 6 Mar 2015. 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 Pakistan. 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.
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?
Sensitivity of Uropathogens (time frame: 3 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 6 Mar 2015.