Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
35 participants
OBSERVATIONAL
2022-01-05
2024-04-05
Brief Summary
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Detailed Description
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Catheter-associated urinary tract infections refers to urinary tract infections occurring in a person whose urinary tract is currently catheterised or has been catheterised within the past 48 hours. Signs and systemic symptoms compatible with сatheter-associated urinary tract infections include new onset or worsening of fever, rigors, altered mental status, malaise, or lethargy with no other identified cause, flank pain, costovertebral angle tenderness, acute haematuria, pelvic discomfort and in those whose catheters have been removed dysuria, urgent or frequent urination and suprapubic pain or tenderness. Microbiologically, сatheter-associated urinary tract infections is defined by microbial growth of \> 103 cfu/mL of one or more bacterial species in a single catheter urine specimen or in a mid-stream voided urine specimen from a patient whose urethral, suprapubic, or condom catheter has been removed within the previous 48 hours.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with cirrhosis and urinary tract infections
Participants collect urine and fecal specimens at first two days when they admit to hospital, after 7-10 days and last two days hospital treatment and during episodes of complications (variceal bleeding, hepatic coma, hepatorenal syndrome).
Urine samples take from patients via clean catch if the patient not have a catheter placed, otherwise take from urinary catheters if present. Straight catheterization utilize if the patient unable to void and doesn't have a catheter placed.
Fecal specimens collect using a toilet specimen collection kit. Clinical, standart laboratory and cultural test, molecular genetic methods, using 16S rRNA gene sequencing of the V4-V5 hypervariable region be administered.
16S rRNA gene sequencing
DNA extraction and 16S rRNA gene sequencing DNA extraction, 16S rRNA gene amplification, and deep sequencing of the 16S rRNA amplicon performe.
The V4-V5 region of the 16S rRNA gene amplify with barcodes for multiplexing.
Participants with cirrhosis without urinary tract infections
Participants ask to collect urine and fecal specimens at first two days when they admit to hospital, after 7-10 days and last two days hospital treatment and during episodes of complications (variceal bleeding, hepatic coma, hepatorenal syndrome).
Urine samples take from patients via clean catch if the patient not have a catheter placed, otherwise take from urinary catheters if present. Straight catheterization utilize if the patient unable to void and doesn't have a catheter placed.
Fecal specimens collect using a toilet specimen collection kit. Clinical, standart laboratory and cultural test, molecular genetic methods, using 16S rRNA gene sequencing of the V4-V5 hypervariable region be administered.
16S rRNA gene sequencing
DNA extraction and 16S rRNA gene sequencing DNA extraction, 16S rRNA gene amplification, and deep sequencing of the 16S rRNA amplicon performe.
The V4-V5 region of the 16S rRNA gene amplify with barcodes for multiplexing.
Interventions
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16S rRNA gene sequencing
DNA extraction and 16S rRNA gene sequencing DNA extraction, 16S rRNA gene amplification, and deep sequencing of the 16S rRNA amplicon performe.
The V4-V5 region of the 16S rRNA gene amplify with barcodes for multiplexing.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* autoimmune diseases
* oncology
* organ transplantation
18 Years
80 Years
ALL
No
Sponsors
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Gomel State Medical University
OTHER
Responsible Party
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Principal Investigators
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Igor Stoma, D.Sc.
Role: PRINCIPAL_INVESTIGATOR
Gomel State Medical University
Locations
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Gomel State Clinical Hospital №3
Homyel, Ilicha Str. 286, Belarus
Countries
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Central Contacts
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Facility Contacts
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References
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Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14.
Mestrovic T, Matijasic M, Peric M, Cipcic Paljetak H, Baresic A, Verbanac D. The Role of Gut, Vaginal, and Urinary Microbiome in Urinary Tract Infections: From Bench to Bedside. Diagnostics (Basel). 2020 Dec 22;11(1):7. doi: 10.3390/diagnostics11010007.
Neugent ML, Hulyalkar NV, Nguyen VH, Zimmern PE, De Nisco NJ. Advances in Understanding the Human Urinary Microbiome and Its Potential Role in Urinary Tract Infection. mBio. 2020 Apr 28;11(2):e00218-20. doi: 10.1128/mBio.00218-20.
Related Links
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In patients with cirrhosis, infections increase mortality 4-fold; 30% of patients die within 1 month after infection and another 30% die by 1 year.
Consequently, studying the relationship between gut microbiota and the subsequent development of bacteriuria and UTI represents an important field of research.
The contribution of the urinary tract microbiome to urinary tract infection and recurrent urinary tract infection
Other Identifiers
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2.15
Identifier Type: -
Identifier Source: org_study_id
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