Antibiotic Sensitivity Testing and Genotypic Caharacterization of EcoliNCT06462261
Phenotypic and Genotypic Characterization of Escherichia Coli
An observational study of Antibiotic Sensitivity Testing and Genotypic Caharacterization of Ecoli, run by Sohag University.
Trial summary
Collection of urine samples Cultivation Antibiotic sensitivity test PCR Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antibiotic Sensitivity Testing and Genotypic Caharacterization of Ecoli
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to Mar 2025
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Adults only with hospital acquired infections
Who may be able to join
- Catheter associated urinary tract infections in patient with catheter more than two 2 days .fever.urine culture with no more than 2 species organisation catheterization .fever.suprapubic tenderness with urine culture more than 105 CFU/Ml
Who cannot join
- asymptomatic bacteriuria UTI before 48 hrs
About this study
Official title: Phenotypic and Genotypic and Antimicrobial Resistance Characterization of Escherichia Coli Causing Nosocomial Urinary Tract Infections in Sohag University Hospitals ,Egypt
Collection of urine samples Cultivation Antibiotic sensitivity test PCR
Read the detailed description
Cultivation on MaCconkey and EMB IMVC test Dis diffusion test Detection of virulence and antibiotic resistance genes by PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Escherichia coli isolates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic sensitivity testing whether sensitive .intermediately sensitive and resistance
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Sensitivity Testing and Genotypic Caharacterization of EcoliStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmin Hassan Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462261
- Sponsor's protocol ID
- Soh-Med-24-03-01MS
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic and Antimicrobial Resistance Characterization of Escherichia Coli Causing Nosocomial Urinary Tract Infections in Sohag University Hospitals ,Egypt
- ClinicalTrials.gov ID
- NCT06462261
- Acronym / sponsor ID
- Soh-Med-24-03-01MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Jun 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.
Collection of urine samples Cultivation Antibiotic sensitivity test PCR
Detailed description
Cultivation on MaCconkey and EMB IMVC test Dis diffusion test Detection of virulence and antibiotic resistance genes by PCR
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Escherichia coli isolates |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults only with hospital acquired infections
Key inclusion criteria (1 listed)
- Catheter associated urinary tract infections in patient with catheter more than two 2 days .fever.urine culture with no more than 2 species organisation catheterization .fever.suprapubic tenderness with urine culture more than 105 CFU/Ml
Key exclusion criteria (1 listed)
- asymptomatic bacteriuria UTI before 48 hrs
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 sensitivity testing whether sensitive .intermediately sensitive and resistance
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Sensitivity Testing and Genotypic Caharacterization of Ecoli, run by Sohag University.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 sensitivity testing whether sensitive .intermediately sensitive and resistance (time frame: 6 month). 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 17 Jun 2024.