Escherichia Coli InfectionsNCT06252428
Detection of Biofilm Among Uropathogenic Escherichia Coli Clinical Isolates in Suez Canal University Hospitals
An observational study of Escherichia Coli Infections, run by Suez Canal University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Escherichia Coli Infections
- How many people
- 47 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients of both sexes and all age groups attending different departments in Suez Canal University hospitals.
Who may be able to join
- 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
Who cannot join
- 1. Patients received antibiotic treatment in the last 48 hours 2. Refusal of the patients to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Escherichia Coli Infections
- Keywords
- Uropathogenic E. coli, biofilm, antibiotic resistance, MTCP, CRA
- Medical subject headings
- Escherichia coli Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start20 Dec 2022
- Primary completion1 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Escherichia Coli InfectionsStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rania Kishk, professor, Study chair, Faculty of Medicine - Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252428
- Sponsor's protocol ID
- Moshera Ahmed Sherif Sherif
- Status last verified
- Mar 2024
- First submitted
- 30 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Biofilm Among Uropathogenic Escherichia Coli Clinical Isolates in Suez Canal University Hospitals
- ClinicalTrials.gov ID
- NCT06252428
- Acronym / sponsor ID
- Moshera Ahmed Sherif Sherif
- Conditions
- Escherichia Coli Infections
- Keywords
- Uropathogenic E. coli, biofilm, antibiotic resistance, MTCP, CRA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients of both sexes and all age groups attending different departments in Suez Canal University hospitals.
Key inclusion criteria (8 listed)
- Patients showing criteria for Symptomatic Urinary Tract Infection (SUTI) according to Center of Diseases and Control criteria (CDC) (CDC, 2022).
- fever (>38.0°C)
- suprapubic tenderness
- costovertebral angle pain or tenderness
- urinary urgency
Key exclusion criteria (1 listed)
- 1. Patients received antibiotic treatment in the last 48 hours 2. Refusal of the patients to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Kishk, professor study chair
Faculty of Medicine - Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Escherichia Coli Infections, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antibiotic resistance (time frame: from 18-24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.