Urinary Tract Infection (Diagnosis)NCT02966977
Extending Urine Analysis By Direct Mass Spectrometry
A study testing Conventional microbiological identification by culture plate and Direct mass spectrometry identification from urine sample in people with Urinary Tract Infection (Diagnosis), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate the effect of an extension of conventional urine diagnostics with mass spectrometry in patients with a suspected UTI. Mass spectrometry is done directly from the urine sample (without an intermediate bacterial culture).The primary outcome is the time from the entry of a urine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection (Diagnosis)
- What is being tested?
- Conventional microbiological identification by culture plate and Direct mass spectrometry identification from urine sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Oct 2016to 15 Apr 2017
- 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
- Patients of the Clinic for Internal Medicine at the University Hospital Basel with a suspected UTI and a minimum of one urine sample sent to the clinical microbiology laboratory.
- Additionally at least one of the following:
- Patients consented to the general (i.e. "hospital-wide") use of their data and samples for research purposes.
- Patients consented to be enrolled in this study (by being informed about this study and signing the study specific consent form).
- Patients who are exempted from the need for a consent by way of an exception in agreement to the decisions of the competent ethics committee.
Who cannot join
- Minors or persons who declined the general use of their data and samples for research purposes (hospital wide consent) and declined or did not decide on the study specific consent form are not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study To Analyse The Influence Of An Extended Urine Analysis By Mass Spectrometry On Internal Medicine Wards At The University Hospital Of Basel
The aim of this study is to evaluate the effect of an extension of conventional urine diagnostics with mass spectrometry in patients with a suspected UTI. Mass spectrometry is done directly from the urine sample (without an intermediate bacterial culture).The primary outcome is the time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment. Secondary outcomes are the time to diagnosis of a therapy relevant UTI, the quantity of antibiotics prescribed per patient and ward and a comparison of the length of hospital stay.
Read the detailed description
Urinary tract infections (UTI) have a high incidence rate and are one of the main reasons for initiating an antibiotic therapy, both, in the ambulatory and hospital setting. Mass spectrometry and improved sample preparation allows same-day identification of the causing agent of an UTI. This could shorten the time of suboptimal and potentially harmful empirical therapy. Additionally adverse effects from and the development of resistance against the applied antibiotic agent could be diminished. Matrix Assisted Laser Desorption Ionization (MALDI)- Time of Flight (TOF) Mass Spectrometry (MS) (MALDI-TOF MS) is already the preferred identification method in an increasing number of laboratories since it outperforms biochemical identification by speed and precision. This study tries to evaluate this new method to identify the causing agent of an UTI and evaluates its clinical implications.
This research project is a clinical trial that intends to analyse urine of patients with suspected urinary tract infections by mass spectrometry. This patient material is conventionally processed and not retrieved particularly for study purposes. Health-related personal data is collected from patients on the wards of the Clinic for Internal Medicine at the University Hospital Basel that have a urine sample analysed during the study period. No health-related personal data is particularly collected for this study.
- Conditions
- Urinary Tract Infection (Diagnosis)
- Being tested
- Conventional microbiological identification by culture plate, Direct mass spectrometry identification from urine sample
- Medical subject headings
- Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional microbiological identification by culture plateOther
Conventional microbiological identification involves a step of overnight-2days growth of bacteria/fungi on culture plates prior to identification by biochemical methods or by mass spectrometry. See also information noted in arm/group description.
Direct mass spectrometry identification from urine sampleOther
The urine sample is concentrated and directly measured by a MALDI-TOF mass spectrometer without an intermediary microbiological culture on agar plates.
| Study group | Role | What they receive |
|---|---|---|
| Conventional microbiological diagnostics | Active comparator | Conventional microbiological identification by culture plate (overnight cultures with subsequent bacterial/fungal identification). Receives: Other: Conventional microbiological identification by culture plate |
| Conventional plus mass spectrometry | Experimental | Conventional microbiological identification by culture plate plus Direct mass spectrometry identification from urine sample. This additional diagnostic procedure is supplied additionally to conventional diagnostics. Receives: Other: Conventional microbiological identification by culture plate; Other: Direct mass spectrometry identification from urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment.
Measured: 1 week
Secondary outcomes (4)
Time to diagnosis of a therapy relevant UTI.
Measured: 1 week
Quantity of antibiotics prescribed per patient and ward.
Measured: 2 weeks
Comparison of the length of hospital stay
Measured: 2 weeks
Comparison of the number of possible complications connected to UTI
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start3 Oct 2016
- Primary completion31 Mar 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection (Diagnosis)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Egli, PD Dr. FAMH, Principal investigator, Clinical Microbiology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966977
- Sponsor's protocol ID
- 2016-01534
- Other IDs
- 2016
- Status last verified
- Jul 2020
- First submitted
- 15 Nov 2016
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study To Analyse The Influence Of An Extended Urine Analysis By Mass Spectrometry On Internal Medicine Wards At The University Hospital Of Basel
- ClinicalTrials.gov ID
- NCT02966977
- Acronym / sponsor ID
- 2016-01534
- Conditions
- Urinary Tract Infection (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 17 Nov 2016 (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 aim of this study is to evaluate the effect of an extension of conventional urine diagnostics with mass spectrometry in patients with a suspected UTI. Mass spectrometry is done directly from the urine sample (without an intermediate bacterial culture).The primary outcome is the time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment. Secondary outcomes are the time to diagnosis of a therapy relevant UTI, the quantity of antibiotics prescribed per patient and ward and a comparison of the length of hospital stay.
Detailed description
Urinary tract infections (UTI) have a high incidence rate and are one of the main reasons for initiating an antibiotic therapy, both, in the ambulatory and hospital setting. Mass spectrometry and improved sample preparation allows same-day identification of the causing agent of an UTI. This could shorten the time of suboptimal and potentially harmful empirical therapy. Additionally adverse effects from and the development of resistance against the applied antibiotic agent could be diminished. Matrix Assisted Laser Desorption Ionization (MALDI)- Time of Flight (TOF) Mass Spectrometry (MS) (MALDI-TOF MS) is already the preferred identification method in an increasing number of laboratories since it outperforms biochemical identification by speed and precision. This study tries to evaluate this new method to identify the causing agent of an UTI and evaluates its clinical implications.
This research project is a clinical trial that intends to analyse urine of patients with suspected urinary tract infections by mass spectrometry. This patient material is conventionally processed and not retrieved particularly for study purposes. Health-related personal data is collected from patients on the wards of the Clinic for Internal Medicine at the University Hospital Basel that have a urine sample analysed during the study period. No health-related personal data is particularly collected for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional microbiological diagnostics | Active comparator | Other: Conventional microbiological identification by culture plateConventional microbiological identification by culture plate (overnight cultures with subsequent bacterial/fungal identification). |
| Conventional plus mass spectrometry | Experimental | Other: Conventional microbiological identification by culture plate, Other: Direct mass spectrometry identification from urine sampleConventional microbiological identification by culture plate plus Direct mass spectrometry identification from urine sample. This additional diagnostic procedure is supplied additionally to conventional diagnostics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of the Clinic for Internal Medicine at the University Hospital Basel with a suspected UTI and a minimum of one urine sample sent to the clinical microbiology laboratory.
- Patients consented to the general (i.e. "hospital-wide") use of their data and samples for research purposes.
- Patients consented to be enrolled in this study (by being informed about this study and signing the study specific consent form).
- Patients who are exempted from the need for a consent by way of an exception in agreement to the decisions of the competent ethics committee.
Key exclusion criteria (1 listed)
- Minors or persons who declined the general use of their data and samples for research purposes (hospital wide consent) and declined or did not decide on the study specific consent form are not included.
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 |
|---|---|---|
| Conventional microbiological identification by culture plateConventional microbiological identification involves a step of overnight-2days growth of bacteria/fungi on culture plates prior to identification by biochemical methods or by mass spectrometry. See also information noted in arm/group description. | Other | Conventional microbiological diagnostics, Conventional plus mass spectrometry |
| Direct mass spectrometry identification from urine sampleThe urine sample is concentrated and directly measured by a MALDI-TOF mass spectrometer without an intermediary microbiological culture on agar plates. | Other | Conventional plus mass spectrometry |
Primary outcome
Time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment.
Time frame: 1 week
4 secondary outcomes
Time to diagnosis of a therapy relevant UTI.
Time frame: 1 week
Quantity of antibiotics prescribed per patient and ward.
Time frame: 2 weeks
Comparison of the length of hospital stay
Time frame: 2 weeks
Comparison of the number of possible complications connected to UTI
Time frame: 4 weeks
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 17 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Adrian Egli, PD Dr. FAMH principal investigator
Clinical Microbiology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional microbiological identification by culture plate and Direct mass spectrometry identification from urine sample in people with Urinary Tract Infection (Diagnosis), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 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 17 Jul 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 Switzerland. 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?
Time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment. (time frame: 1 week). 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 17 Jul 2020.