NCT06252428

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

January 30, 2024

Last Update Submit

March 3, 2024

Conditions

Keywords

Uropathogenic E. colibiofilmantibiotic resistanceMTCPCRA

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients of both sexes and all age groups attending different departments in Suez Canal University hospitals.

You may qualify if:

  • 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

You may not qualify if:

  • \. Patients received antibiotic treatment in the last 48 hours 2. Refusal of the patients to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Suez canal university

Ismailia, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine specimens will be collected under aseptic precautions from clinically suspected patients with UTIs in different wards in Suez Canal University hospitals.

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Rania Kishk, professor

    Faculty of Medicine - Suez Canal University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 9, 2024

Study Start

December 20, 2022

Primary Completion

February 1, 2024

Study Completion

February 20, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations