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Completed

NCT Number: NCT06252428

Detection of Biofilm Among Uropathogenic Escherichia Coli Clinical Isolates in Suez Canal University Hospitals

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Suez canal university

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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