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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04598971
Other study ID # 2020-00779
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date December 13, 2021

Study information

Verified date October 2020
Source Centre Hospitalier Universitaire Vaudois
Contact Charlotte Desponds, BM
Phone +41795561934
Email Charlotte.Desponds@unil.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 13, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Switzerland UniSanté Lausanne VD

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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