Pseudomonas Aeruginosa InfectionNCT06417593
Phenotypic and Genotypic Characteristics of Pseudomonas Aeruginosa Isolates in Sohag University Hospitals
An observational study of Pseudomonas Aeruginosa Infection, run by Sohag University at 1 site in Egypt.
Trial summary
Isolation and identification of Pseudomonas aeruginosa using basic microbiological methods, such as Gram staining, cultivation on cetrimide agar and biochemical reactions from Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator… Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Pseudomonas Aeruginosa Infection
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections will be obtained under complete aseptic precautions.
Who may be able to join
- Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections will be obtained under complete aseptic precautions.
Who cannot join
- Any infection before 48 hours of patient admission at Hospital
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine Sohag university hospital
Sohag
martina
About this study
Isolation and identification of Pseudomonas aeruginosa using basic microbiological methods, such as Gram staining, cultivation on cetrimide agar and biochemical reactions from Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections that will be obtained under complete aseptic precautions.
- Conditions
- Pseudomonas Aeruginosa Infection
- Medical subject headings
- Pseudomonas Infections
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 |
|---|---|---|
| group1 | Pseudomonas Aeruginosa Isolates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation and identification of pseudomonas aeruginosa causing different nosocomial infections.
Isolation and identification of Pseudomonas aeruginosa using basic microbiological methods, such as Gram staining, cultivation on cetrimide agar and biochemical reactions
Measured: 6 months
Identification of antibiotic susceptibility pattern of isolated strains of pseudomonas
Antibiotic susceptibility testing of the isolates will be performed using disc diffusion method according to clinical laboratory standards institute (CLSI) guidelines
Measured: 6 months
Detection of biofilm forming isolates
Detection of biofilm forming isolates by tissue culture plate method.
Measured: 6 months
Detection of virulence and antibiotic resistance genes of pseudomonas aeruginosa.
Detection of virulence and antibiotic resistance genes by conventional Polymerase Chain Reaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Apr 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomonas Aeruginosa InfectionStudies 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, Martina Gamil Fayez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417593
- Sponsor's protocol ID
- Soh-Med-24-04-016MS
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Characteristics of Pseudomonas Aeruginosa Isolates in Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06417593
- Acronym / sponsor ID
- Soh-Med-24-04-016MS
- Conditions
- Pseudomonas Aeruginosa Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 16 May 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.
Isolation and identification of Pseudomonas aeruginosa using basic microbiological methods, such as Gram staining, cultivation on cetrimide agar and biochemical reactions from Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections that will be obtained under complete aseptic precautions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group1 | – | –Pseudomonas Aeruginosa Isolates |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections will be obtained under complete aseptic precautions.
Key inclusion criteria (1 listed)
- Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections will be obtained under complete aseptic precautions.
Key exclusion criteria (1 listed)
- Any infection before 48 hours of patient admission at Hospital
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
Isolation and identification of pseudomonas aeruginosa causing different nosocomial infections.
Time frame: 6 months
Isolation and identification of Pseudomonas aeruginosa using basic microbiological methods, such as Gram staining, cultivation on cetrimide agar and biochemical reactions
Identification of antibiotic susceptibility pattern of isolated strains of pseudomonas
Time frame: 6 months
Antibiotic susceptibility testing of the isolates will be performed using disc diffusion method according to clinical laboratory standards institute (CLSI) guidelines
Detection of biofilm forming isolates
Time frame: 6 months
Detection of biofilm forming isolates by tissue culture plate method.
Detection of virulence and antibiotic resistance genes of pseudomonas aeruginosa.
Time frame: 6 months
Detection of virulence and antibiotic resistance genes by conventional Polymerase Chain Reaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Yes
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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.
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 Pseudomonas Aeruginosa Infection, run by Sohag 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 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 20 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Gamil Fayez, Demonstrator at Microbiology (01272602453, martina.gameel@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation and identification of pseudomonas aeruginosa causing different nosocomial infections. (time frame: 6 months). The study lists 4 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 20 May 2024.