- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06252428
Detection of Biofilm Among Uropathogenic Escherichia Coli Clinical Isolates in Suez Canal University Hospitals
March 3, 2024 updated by: Suez Canal University
This descriptive cross-sectional study will beconducted in Suez Canal University Hospitals (SCUHs) in Ismailia, Egypt.
The study aims to detect Escherichia coli biofilm producers to improve prognosis and treatment and reduce morbidity and mortality rates due to this infection.
Study Overview
Status
Completed
Conditions
Detailed Description
Forty seven clinical isolates of non-duplicated UPEC will be collected from clinically suspected cases of UTI in different departments in SCUHs.
Isolates will be identified as E. coli by colony morphology, Gram staining and biochemical reactions.
Antimicrobial sensitivity testing will be performed by Kirby-Bauer disc diffusion method on Muller-Hinton agar plate.
The detection of biofilm will be carried out by Congo Red Agar (CRA) method and modified tissue culture plate (MTCP) method.
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ismailia, Egypt
- Faculty of Medicine, Suez canal university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
All patients of both sexes and all age groups attending different departments in Suez Canal University hospitals.
Description
Inclusion Criteria:
- Patients showing criteria for Symptomatic Urinary Tract Infection (SUTI) according to Center of Diseases and Control criteria (CDC) (CDC, 2022).
Patient has at least one of the following signs or symptoms:
- fever (>38.0°C)
- suprapubic tenderness
- costovertebral angle pain or tenderness
- urinary urgency
- urinary frequency
- dysuria
Exclusion Criteria:
- 1. Patients received antibiotic treatment in the last 48 hours 2. Refusal of the patients to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
antibiotic resistance
Time Frame: from 18-24 hours
|
Susceptibility testing will be performed according to the standard Kirby-Bauer disk diffusion method on Mueller Hinton agar and interpreted according to the Clinical and Laboratory Standard Institute (CLSI) guidelines.
Antibiotic discs include Amoxicillin-clavulanate, Piperacillin-tazobactam, Cefotaxime, Ceftazidime, Aztreonam, Imipenem, Gentamicin, Amikacin, Norfloxacin, ciprofloxacin, levofloxacin, Trimethoprim-sulfamethoxazole, Nitrofurantoin.
|
from 18-24 hours
|
Congo red Agar method (CRA)
Time Frame: 24 to 48 hours
|
The medium will be prepared by adding 37 gm brain heart infusion (BHI) powder, 50 gm sucrose and 10 gm agar to 900 ml distilled water and autoclaved at 121°C for 15 minutes.
Congo red will be prepared separately by dissolving 0.8 gm of congo red stain in 100 ml distilled water as concentrated aqueous solution and autoclaved at 121°C for 15 minutes and thenit will be added to the previous media when it cooled to 55°C.
The congo red agar will be distributed in sterile plates.
Plates will be inoculated by the test bacteria and incubated aerobically for 24 to 48 hours at 37°C.
Positive results will be indicated by black colonies with a dry crystalline consistency.
Weak slime producers usually remain pink.
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24 to 48 hours
|
Modified tissue culture plate method (MTCP)
Time Frame: up to 24 hours
|
All isolates will be screened for their ability to form biofilm by the TCP method with a modification in duration of incubation, which will be extended to 24 hours and the addition of glucose.
|
up to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Rania Kishk, professor, Faculty of Medicine - Suez Canal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2022
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
February 20, 2024
Study Registration Dates
First Submitted
January 30, 2024
First Submitted That Met QC Criteria
February 7, 2024
First Posted (Actual)
February 9, 2024
Study Record Updates
Last Update Posted (Actual)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 3, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Moshera Ahmed Sherif Sherif
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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