Urinary Tract InfectionsPHURINENCT04598971
Urine pH and Urinary Tract Infection
An observational study of Urinary Tract Infections and Urinary Stone, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Urinary tract infections (UTI) affect the urine pH and may lead to salt precipitation such as struvite. Bacteria with urease activity are known to alkalinise urine, but not much is known on how pH is changing over time during UTI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Urinary Stone
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2020to 13 Dec 2021
- 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
- Adult, Older adult
Study population: Patient consulting the primary care unit of the medical outpatient clinic UniSanté in Lausanne will be asked to participate.
Who may be able to join
- Symptoms of dysuria, pollakiuria, no fever AND
- urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml)
- Group 2. Pyelonephritis
- Unilateral flank pain, pollakiuria, dysuria, fever (>38.5°C) AND
- urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml)
Who cannot join
- known urinary tract anatomic abnormalities
- Presence of a urine catheter
- Sepsis - septic shock
- Patient taking drug interfering with urine pH (diuretics, citrate, acetazolamide, topiramate,...)
- Patients with UTI diagnosed in the preceding month
- Patients having received antibiotics during the preceding month
Show all 11Show fewer
- Male patient with a diagnosis of prostatitis
- Presence of infected kidney cyst
- Patient with diabetes
- Pregnant female
- Patient with obstructive pyelonephritis
Trial locations and contacts
1 site in 1 country.
Alexandre Gouveia, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
UniSanté
Lausanne, Canton of Vaud, 1011
Alexandre Gouveia, MD, +41213144905, Alexandre.Gouveia@unisant.ch
About this study
Official title: Consequences of UTI on Urine pH
Urinary tract infections (UTI) affect the urine pH and may lead to salt precipitation such as struvite. Bacteria with urease activity are known to alkalinise urine, but not much is known on how pH is changing over time during UTI.
This study aims at following urine pH progression at the time of diagnosis of UTI and during the treatment phase.
Description of the change in urine pH over time will help understanding the risk of struvite formation and potential timing of intervention.
Read the detailed description
Adults presenting with UTI symptoms will be screened for infection and instructed to monitor urine pH during the course of treatment and 1 week after. Urine pH will be measured by the patients using calibrated pH-stix. Type of bacteria, antibiotics, and the type of diet will be monitored during the study.
- Conditions
- Urinary Tract Infections, Urinary Stone
- Keywords
- urine pH
- Medical subject headings
- Urinary Tract Infections, Urinary Calculi
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 |
|---|---|---|
| Cystitis | Patients with lower UTI will be included in this group | |
| Pyelonephritis | Patients with higher UTI will be included in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine pH
Urine pH is monitored by the patient every morning during the treatment phase and 7 days after the end of treatment
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion13 Dec 2021 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Bonny, Centre Hospitalier Universitaire Vaudois
- Investigators
- Olivier Bonny, MD-PhD, Principal investigator, CHUV-Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598971
- Sponsor's protocol ID
- 2020-00779
- Acronym
- PHURINE
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of UTI on Urine pH
- ClinicalTrials.gov ID
- NCT04598971
- Acronym / sponsor ID
- PHURINE / 2020-00779
- Conditions
- Urinary Tract Infections, Urinary Stone
- Keywords
- urine pH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 13 Dec 2021 (estimated)
- First posted
- 22 Oct 2020 (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.
Urinary tract infections (UTI) affect the urine pH and may lead to salt precipitation such as struvite. Bacteria with urease activity are known to alkalinise urine, but not much is known on how pH is changing over time during UTI.
This study aims at following urine pH progression at the time of diagnosis of UTI and during the treatment phase.
Description of the change in urine pH over time will help understanding the risk of struvite formation and potential timing of intervention.
Detailed description
Adults presenting with UTI symptoms will be screened for infection and instructed to monitor urine pH during the course of treatment and 1 week after. Urine pH will be measured by the patients using calibrated pH-stix. Type of bacteria, antibiotics, and the type of diet will be monitored during the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystitis | – | –Patients with lower UTI will be included in this group |
| Pyelonephritis | – | –Patients with higher UTI will be included in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient consulting the primary care unit of the medical outpatient clinic UniSanté in Lausanne will be asked to participate.
Key inclusion criteria (5 listed)
- Symptoms of dysuria, pollakiuria, no fever AND
- urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml)
- Group 2. Pyelonephritis
- Unilateral flank pain, pollakiuria, dysuria, fever (>38.5°C) AND
- urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml)
Key exclusion criteria (11 listed)
- known urinary tract anatomic abnormalities
- Presence of a urine catheter
- Sepsis - septic shock
- Patient taking drug interfering with urine pH (diuretics, citrate, acetazolamide, topiramate,...)
- Patients with UTI diagnosed in the preceding month
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
Urine pH
Time frame: 21 days
Urine pH is monitored by the patient every morning during the treatment phase and 7 days after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Urinary Tract Infections
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
RecruitingPhase 2
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
Chronic Urinary Tract Infection
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
Alexandre Gouveia, MD contact
Olivier Bonny, MD-PhD principal investigator
CHUV-Lausanne
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 and Urinary Stone, run by Centre Hospitalier Universitaire Vaudois 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 11 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: status not confirmed, as of the sponsor's last update on 22 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Desponds, BM (+41795561934, Charlotte.Desponds@unil.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine pH (time frame: 21 days). 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 22 Oct 2020.