NCT04598971

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

October 13, 2020

Last Update Submit

October 19, 2020

Conditions

Keywords

urine pH

Outcome Measures

Primary Outcomes (1)

  • Urine pH

    Urine pH is monitored by the patient every morning during the treatment phase and 7 days after the end of treatment

    21 days

Study Arms (2)

Cystitis

Patients with lower UTI will be included in this group

Pyelonephritis

Patients with higher UTI will be included in this group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient consulting the primary care unit of the medical outpatient clinic UniSanté in Lausanne will be asked to participate.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniSanté

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Urinary Tract InfectionsUrinary Calculi

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Bonny, MD-PhD

    CHUV-Lausanne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Desponds, BM

CONTACT

Alexandre Gouveia, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 22, 2020

Study Start

August 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 13, 2021

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations