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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06252428
Other study ID # Moshera Ahmed Sherif Sherif
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 20, 2022
Est. completion date February 20, 2024

Study information

Verified date March 2024
Source Suez Canal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date February 20, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of Medicine, Suez canal university Ismailia

Sponsors (1)

Lead Sponsor Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary antibiotic resistance 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
Primary Congo red Agar method (CRA) 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. 24 to 48 hours
Primary Modified tissue culture plate method (MTCP) 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
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