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Urine pH and Urinary Tract Infection (PHURINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598971
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Olivier Bonny, Centre Hospitalier Universitaire Vaudois

Study Description
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Brief 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.

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.


Condition or disease
Urinary Tract Infections Urinary Stone

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
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Consequences of UTI on Urine pH
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 13, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Cystitis
Patients with lower UTI will be included in this group
Pyelonephritis
Patients with higher UTI will be included in this group


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patient consulting the primary care unit of the medical outpatient clinic UniSanté in Lausanne will be asked to participate.
Criteria

Group 1. Cystitis

Inclusion Criteria:

  • Symptoms of dysuria, pollakiuria, no fever AND
  • urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml)

Group 2. Pyelonephritis

Inclusion Criteria:

  • Unilateral flank pain, pollakiuria, dysuria, fever (>38.5°C) AND
  • urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml)

Exclusion Criteria (both groups):

  • 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
  • Male patient with a diagnosis of prostatitis
  • Presence of infected kidney cyst
  • Patient with diabetes
  • Pregnant female
  • Patient with obstructive pyelonephritis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598971


Contacts
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Contact: Charlotte Desponds, BM +41795561934 Charlotte.Desponds@unil.ch
Contact: Alexandre Gouveia, MD Alexandre.Gouveia@unisante.ch

Locations
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Switzerland
UniSanté Recruiting
Lausanne, VD, Switzerland, 1011
Contact: Alexandre Gouveia, MD    +41213144905    Alexandre.Gouveia@unisant.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Olivier Bonny, MD-PhD CHUV-Lausanne
More Information
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Responsible Party: Olivier Bonny, Associate professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04598971    
Other Study ID Numbers: 2020-00779
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olivier Bonny, Centre Hospitalier Universitaire Vaudois:
urine pH
Additional relevant MeSH terms:
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Infections
Urinary Tract Infections
Urinary Calculi
Urolithiasis
 Urologic Diseases
Calculi
Pathological Conditions, Anatomical