Urinary Tract InfectionsNCT05141188
Extended Spectrum Beta Lactamase Producing Organisms In Urinary Tract Infections
An observational study of Urinary Tract Infections, run by Sohag University.
Trial summary
Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy .Resistance to antibiotic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Nov 2022
- 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
- Child, Adult, Older adult
Study population: This study will be conducted on all patients who are diagnosed that have urinary tract infections
Who may be able to join
- This study will be conducted on a group of patients who are diagnosed that have urinary tract infections
Who cannot join
- The cases that do not give bacterial growth .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence Of Extended Spectrum Beta Lactamase Producing Organisms In Urinary Tract Infections
Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy .Resistance to antibiotic treatment in patients with urinary tract infections (UTIs) is a representative example of the increasing problem of antimicrobial resistance. Extended-spectrum β-lactamases (ESBLs) has emerged as an important mechanism of resistance in Gram-negative bacteria.
Read the detailed description
Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy .
Resistance to antibiotic treatment in patients with urinary tract infections (UTIs) is a representative example of the increasing problem of antimicrobial resistance. Extended-spectrum β-lactamases (ESBLs) has emerged as an important mechanism of resistance in Gram-negative bacteria.
Bacterial production of extended-spectrum β-lactamases (ESBL) significantly reduces the efficacy of the most commonly used beta-lactam antibiotics for the empiric therapy of infections caused by putative Gram-negative .
Extended Spectrum Beta-Lactamase (ESBL) is derived from the mutated beta-lactamase enzyme, Beta-lactamase is an enzyme produced by bacteria that acts to inactivate beta-lactam class of antibiotics .
Extended Spectrum Beta-Lactamase is most commonly produced by the Enterobacteriaceae group, especially Escherichia coli and Klebsiella pneumonia.
ESBL-producing bacteria can also be resistant to the antibiotics class of aminoglycoside, fluoroquinolone, tetracycline, chloramphenicol, and sulfamethoxazole-trimethoprim.
The presence of ESBL-producing bacteria in an infection can result in treatment failure. Antibiotic resistance causes a decrease in the effectiveness of treatment, increases transmission of infection, increases mortality, and increases the cost of health care, while the discovery of new antibiotics is getting less and less
- Conditions
- Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to indicate the spread of extended spectrum beta lactamase producing gram negative bacteria ( that isolated from the urine of patients with urinary tract infections based on their susceptibility to antimicrobial agents )
This study will be conducted on a group of patients who are diagnosed that have urinary tract infections .
- Methods of the study:
Antibiotic susceptibility will be examined on disk diffusion test on Mueller-Hinton agar (MHA) . The zones of growth inhibition around each of the antibiotic disks are measured to the nearest millimeter
Measured: through study completion, an average of 1 year
The aim of this study is to indicate the spread of extended spectrum beta lactamase producing gram negative bacteria ( that isolated from the urine of patients with urinary tract infections based on their susceptibility to antimicrobial agents )
This study will be conducted on a group of patients who are diagnosed that have urinary tract infections .
- Methods of the study:
Antibiotic susceptibility will be performed by automated method Vitek -2 system that measured by minimal inhibitory concentration (MIC) .
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayada Shaaban Amin, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141188
- Sponsor's protocol ID
- Soh-Med-21-10-10
- Status last verified
- Nov 2021
- First submitted
- 7 Oct 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Extended Spectrum Beta Lactamase Producing Organisms In Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT05141188
- Acronym / sponsor ID
- Soh-Med-21-10-10
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 2 Dec 2021 (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.
Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy .Resistance to antibiotic treatment in patients with urinary tract infections (UTIs) is a representative example of the increasing problem of antimicrobial resistance. Extended-spectrum β-lactamases (ESBLs) has emerged as an important mechanism of resistance in Gram-negative bacteria.
Detailed description
Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy .
Resistance to antibiotic treatment in patients with urinary tract infections (UTIs) is a representative example of the increasing problem of antimicrobial resistance. Extended-spectrum β-lactamases (ESBLs) has emerged as an important mechanism of resistance in Gram-negative bacteria.
Bacterial production of extended-spectrum β-lactamases (ESBL) significantly reduces the efficacy of the most commonly used beta-lactam antibiotics for the empiric therapy of infections caused by putative Gram-negative .
Extended Spectrum Beta-Lactamase (ESBL) is derived from the mutated beta-lactamase enzyme, Beta-lactamase is an enzyme produced by bacteria that acts to inactivate beta-lactam class of antibiotics .
Extended Spectrum Beta-Lactamase is most commonly produced by the Enterobacteriaceae group, especially Escherichia coli and Klebsiella pneumonia.
ESBL-producing bacteria can also be resistant to the antibiotics class of aminoglycoside, fluoroquinolone, tetracycline, chloramphenicol, and sulfamethoxazole-trimethoprim.
The presence of ESBL-producing bacteria in an infection can result in treatment failure. Antibiotic resistance causes a decrease in the effectiveness of treatment, increases transmission of infection, increases mortality, and increases the cost of health care, while the discovery of new antibiotics is getting less and less
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be conducted on all patients who are diagnosed that have urinary tract infections
Key inclusion criteria (1 listed)
- This study will be conducted on a group of patients who are diagnosed that have urinary tract infections
Key exclusion criteria (1 listed)
- The cases that do not give bacterial growth .
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
The aim of this study is to indicate the spread of extended spectrum beta lactamase producing gram negative bacteria ( that isolated from the urine of patients with urinary tract infections based on their susceptibility to antimicrobial agents )
Time frame: through study completion, an average of 1 year
This study will be conducted on a group of patients who are diagnosed that have urinary tract infections . * Methods of the study: Antibiotic susceptibility will be examined on disk diffusion test on Mueller-Hinton agar (MHA) . The zones of growth inhibition around each of the antibiotic disks are measured to the nearest millimeter
The aim of this study is to indicate the spread of extended spectrum beta lactamase producing gram negative bacteria ( that isolated from the urine of patients with urinary tract infections based on their susceptibility to antimicrobial agents )
Time frame: through study completion, an average of 1 year
This study will be conducted on a group of patients who are diagnosed that have urinary tract infections . * Methods of the study: Antibiotic susceptibility will be performed by automated method Vitek -2 system that measured by minimal inhibitory concentration (MIC) .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, 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 2 Dec 2021. 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?
Contact Mayada S Amin (01098839535, maiada011200@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of this study is to indicate the spread of extended spectrum beta lactamase producing gram negative bacteria ( that isolated from the urine of patients with urinary tract infections based on their susceptibility to antimicrobial agents ) (time frame: through study completion, an average of 1 year). The study lists 2 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 2 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.