Urinary Tract InfectionNCT01060956
The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures
A study testing reporting of two different bacteria in urine culture and reporting "mixed growth" on urine culture in people with Urinary Tract Infection, run by Shaare Zedek Medical Center.
Trial summary
The purpose of this study is to determine whether identification of two different bacteria in urine culture of patients with indwelling catheter has a clinical impact - change in antibiotic, duration of antibiotic, days to clinical resolution and length of stay in hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- reporting of two different bacteria in urine culture and reporting "mixed growth" on urine culture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2011
- Phase
- Interventional
- 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
Who may be able to join
- Adults hospitalized with indwelling urinary catheter in growth of two bacteria in urine culture
Who cannot join
- Positive blood cultures or no blood cultures taken
About this study
The purpose of this study is to determine whether identification of two different bacteria in urine culture of patients with indwelling catheter has a clinical impact - change in antibiotic, duration of antibiotic, days to clinical resolution and length of stay in hospital.
The microbiology laboratory will randomized urine cultures with two bacteria from indwelling catheter to either reporting identity and susceptibility of the bacteria or reporting "mixed growth".
- Conditions
- Urinary Tract Infection
- Being tested
- reporting of two different bacteria in urine culture, reporting "mixed growth" on urine culture
- Keywords
- Urinary tract infection with two bacteria in culture
- 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.
reporting of two different bacteria in urine cultureOther
reporting of two different bacteria in urine culture
reporting "mixed growth" on urine cultureOther
reporting "mixed growth" on urine culture
| Study group | Role | What they receive |
|---|---|---|
| Reporting on two bacteria in urine culture | Active comparator | The microbiology laboratory will report on the isolation and susceptibilities of two different bacteria in urine culture Receives: Other: reporting of two different bacteria in urine culture |
| reporting "mixed growth" | Placebo comparator | The microbiology laboratory will report on mixed growth in urine culture Receives: Other: reporting "mixed growth" on urine culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of antibiotic treatment
Measured: During the episode of urinary tract infection
Secondary outcomes (3)
Days to clinical resolution
Measured: Duration of urinary tract infection and duration of hospitalization
Increase/decrease in the spectrum of antibiotic
Measured: Duration of urinary tract infection and duration of hospitalization
Length of stay in hospital
Measured: Duration of urinary tract infection and duration of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Amos M Yinnon, MD, Prof, Principal investigator, Hebrew university, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060956
- Sponsor's protocol ID
- UTI1
- Status last verified
- Feb 2010
- First submitted
- 1 Feb 2010
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures
- ClinicalTrials.gov ID
- NCT01060956
- Acronym / sponsor ID
- UTI1
- Conditions
- Urinary Tract Infection
- Keywords
- Urinary tract infection with two bacteria in culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Feb 2010 (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.
The purpose of this study is to determine whether identification of two different bacteria in urine culture of patients with indwelling catheter has a clinical impact - change in antibiotic, duration of antibiotic, days to clinical resolution and length of stay in hospital.
The microbiology laboratory will randomized urine cultures with two bacteria from indwelling catheter to either reporting identity and susceptibility of the bacteria or reporting "mixed growth".
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reporting on two bacteria in urine culture | Active comparator | Other: reporting of two different bacteria in urine cultureThe microbiology laboratory will report on the isolation and susceptibilities of two different bacteria in urine culture |
| reporting "mixed growth" | Placebo comparator | Other: reporting "mixed growth" on urine cultureThe microbiology laboratory will report on mixed growth in urine culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults hospitalized with indwelling urinary catheter in growth of two bacteria in urine culture
Key exclusion criteria (1 listed)
- Positive blood cultures or no blood cultures taken
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 |
|---|---|---|
| reporting of two different bacteria in urine culturereporting of two different bacteria in urine culture | Other | Reporting on two bacteria in urine culture |
| reporting "mixed growth" on urine culturereporting "mixed growth" on urine culture | Other | reporting "mixed growth" |
Primary outcome
Change of antibiotic treatment
Time frame: During the episode of urinary tract infection
3 secondary outcomes
Days to clinical resolution
Time frame: Duration of urinary tract infection and duration of hospitalization
Increase/decrease in the spectrum of antibiotic
Time frame: Duration of urinary tract infection and duration of hospitalization
Length of stay in hospital
Time frame: Duration of urinary tract infection and duration of hospitalization
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 27 Jul 2011.
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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.
Amos M Yinnon, MD, Prof principal investigator
Hebrew university, Jerusalem, Israel
Questions about this trial
What is this clinical trial studying?
A study testing reporting of two different bacteria in urine culture and reporting "mixed growth" on urine culture in people with Urinary Tract Infection, run by Shaare Zedek Medical Center.
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 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change of antibiotic treatment (time frame: During the episode of urinary tract infection). 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 27 Jul 2011.