Urinary Tract InfectionsNCT04950582
In Vitro Analysis of Human Urine With the CloudCath Device
An observational study of Urinary Tract Infections, run by CloudCath at 1 site in Mexico.
Trial summary
This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Spectral characteristics assessment
- How many people
- 500 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jun 2021to 15 Jun 2024
- How long will I take part?
- 1 Week
- 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: patients with indwelling urinary catheters
Who may be able to join
- provide a signed informed consent
- patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral)
Who cannot join
- any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study
- currently taking antibiotics for any reason other than for treatment of urinary tract infection (UTI)
- suprapubic bladder catheter implanted
Trial locations and contacts
1 site in 1 country.
About this study
This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine.
Read the detailed description
Specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection.
To evaluate the performance of the CloudCath Device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months.
Each sample will be divided into multiple aliquots. One part will be analyzed using the CloudCath Device and reference devices. Another part may be submitted to an independent lab for standard analytical tests.
- Conditions
- Urinary Tract Infections
- Being tested
- Spectral characteristics assessment
- 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.
Spectral characteristics assessmentDiagnostic test
Urine sample analysis for evidence of urinary tract infection
| Study group | Role | What they receive |
|---|---|---|
| UTI-high risk patients | patients who are at high risk for developing a urinary tract infection (UTI). Receives: Diagnostic Test: Spectral characteristics assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral characteristics of urine specimens
A quantitative analysis of the spectral properties of the urine specimen using a proprietary algorithm that results in a quantitative CloudCath Turbidity Score (0-100, with higher values indicating more turbidity).
Measured: During the period of time that the patient is catheterized (expected to be up to ~1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start4 Jun 2021
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Why it stopped: temporary pause due to business priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- CloudCath
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Briggs, MD, PhD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950582
- Sponsor's protocol ID
- CC-L-008
- Status last verified
- Sep 2023
- First submitted
- 9 Jun 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Analysis of Human Urine With the CloudCath Device
- ClinicalTrials.gov ID
- NCT04950582
- Acronym / sponsor ID
- CC-L-008
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: temporary pause due to business priorities
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- CloudCathIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 6 Jul 2021 (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.
This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine.
Detailed description
Specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection.
To evaluate the performance of the CloudCath Device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months.
Each sample will be divided into multiple aliquots. One part will be analyzed using the CloudCath Device and reference devices. Another part may be submitted to an independent lab for standard analytical tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UTI-high risk patients | – | Diagnostic Test: Spectral characteristics assessmentpatients who are at high risk for developing a urinary tract infection (UTI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with indwelling urinary catheters
Key inclusion criteria (2 listed)
- provide a signed informed consent
- patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral)
Key exclusion criteria (3 listed)
- any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study
- currently taking antibiotics for any reason other than for treatment of urinary tract infection (UTI)
- suprapubic bladder catheter implanted
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 |
|---|---|---|
| Spectral characteristics assessmentUrine sample analysis for evidence of urinary tract infection | Diagnostic test | UTI-high risk patients |
Primary outcome
Spectral characteristics of urine specimens
Time frame: During the period of time that the patient is catheterized (expected to be up to ~1 week)
A quantitative analysis of the spectral properties of the urine specimen using a proprietary algorithm that results in a quantitative CloudCath Turbidity Score (0-100, with higher values indicating more turbidity).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
Ben Briggs, MD, PhD study director
University of California, San Francisco
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, run by CloudCath at 1 site in Mexico.
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 3 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: paused, as of the sponsor's last update on 21 Sep 2023. 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 Mexico. 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?
Results are not available in the source record.
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?
Spectral characteristics of urine specimens (time frame: During the period of time that the patient is catheterized (expected to be up to ~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 21 Sep 2023.