Detection of Type VI Secretion System in K.PneumoniaeKlebsiellaNCT05516654
Type VI Secretion System in Klebsiella Pneumoniae
An observational study of Detection of Type VI Secretion System in K.Pneumoniae and Detection of Relation to Ab Resistance, Biofilm, run by Sohag University at 1 site in Egypt.
Trial summary
Klebsiella pneumoniae (K. pneumoniae) is an important opportunistic pathogen contributing to nosocomial and antimicrobial-resistant infections. The increasing prevalence of infections caused by multidrug-resistant K. Read more about this study
- Who is it for?
- Ages 12 weeks to 90 years
- Conditions the study is for
- Detection of Type VI Secretion System in K.Pneumoniae, Detection of Relation to Ab Resistance, Biofilm
- What is being tested?
- Routine bacteriological cultures, Identification of the organism and antibiotic sensitivity will be done by VITEK II and Detection of biofilm formation
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2022to 30 Sep 2023
- 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 12 weeks to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: -Samples(pus, urine, blood, peritoneal fluid) will be collected from different departments at Sohag university hospital. Clinical Data will be obtained as: 1. Data about clinical manifestations including fever, expectoration, pus from wounds, and diarrhea, urinary symptoms, symptoms of upper respiratory tract infections, symptoms of spontaneous bacterial peritonitis. 2. Laboratory investigation: A-CBC B - CRP C- urine analysis D- serum creatinine E - Serum bilirubin F- ALT G -AST 3. Routine bacteriological cultures will be done. 4. Automated identification of the organism and antibiotic sensitivity will be done by VITEK II. 5. Biofilm formation to the collected organism by tissue culture plate method. 6. Molecular detection of Type VI Secretion System genes ,capsular serotyping( k1, k2) and FimH genes by PCR.
Who may be able to join
- All patients suffering from infections that can be caused by Klebsiella Pneumoniae.
Who cannot join
- Samples diagnosed to have organisms other than Klebsiella Pneumoniae
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Medicine
Sohag, 82524
Noha S Shafik, lecturer, 00201067261504, Nohasaber@med.sohag.edu.eg
Nesma A Mohammed, Lecturer, 00201006780725, Nesmaaateef@med.sohag.edu.eg
About this study
Official title: Type VI Secretion System in Klebsiella Pneumoniae Relation to Antibiotic Resistance and Biofilm Formation
Klebsiella pneumoniae (K. pneumoniae) is an important opportunistic pathogen contributing to nosocomial and antimicrobial-resistant infections. The increasing prevalence of infections caused by multidrug-resistant K. pneumoniae has emerged as a major clinical and public health threat, while the serous organ and life-threatening infections caused by highly virulent K. pneumoniae have also emerged( Russo and Marr, 2019; Wyres et al., 2020).
Read the detailed description
Both drug-resistant and highly virulent K. pneumoniae have brought major challenges to clinical treatment and stimulated interest in studying K. pneumoniae. However, knowledge of the genomics, ecology, and pathogenicity of K. pneumoniae is relatively limited. Recently, the type VI secretion system (T6SS) was identified as a virulence factor in K. pneumoniae (Martin and Bachman, 2018). Furthermore, K. pneumoniae was found to exploit the T6SS nano-weapon to destroy bacterial competitors and fungi (Storey et al., 2020).
The bacterial Type VI Secretion System (T6SS) is a membrane-attached contractile phage tail that is physically and Mechanistically similar to a membrane-linked intracellular contractile phage tail. T6SS spike and tube elements, as well as anti-bacterial and anti-eukaryotic effectors, are propelled out of predatory T6SS positive cells and into target cells by a fast conformational shift in the structural framework of a sheath protein complex, according to recent research (Kudryashev et al., 2015).
However, the limited studies and lack of information on the T6SS in K. pneumoniae necessitate further exploration to clarify the physiological metabolism and pathogenic information of this clinically important bacterial species.
- Conditions
- Detection of Type VI Secretion System in K.Pneumoniae, Detection of Relation to Ab Resistance, Biofilm
- Being tested
- Routine bacteriological cultures, Identification of the organism and antibiotic sensitivity will be done by VITEK II, Detection of biofilm formation, Molecular detection by PCR
- Keywords
- Type IV, secretion system, Klebsiella Pneumoniae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine bacteriological culturesDiagnostic test
culture of different samples on different culture media as nutrient agar, blood agar, MacConkey agar, EMB agar, TSI
Identification of the organism and antibiotic sensitivity will be done by VITEK IIDiagnostic test
Automated identification of the organism and antibiotic sensitivity will be done by VITEK II
Detection of biofilm formationDiagnostic test
Detection of Biofilm formation to the collected organism by tissue culture plate method.
Molecular detection by PCRDiagnostic test
Molecular detection of Type VI Secretion System genes, capsular serotyping( k1, k2), and FimH genes by PCR.
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation and identification of Klebsiella Pneumoniae isolated from different samples and determination of their antibiotics profile
Measured: 1 september 2022 to 1 November 2022
Detection of Type VI Secretion System In Klebsiella Pneumoniae and its relation to Antibiotic Resistance and biofilm formation
Measured: 2 November 2022 to February 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start10 Sep 2022
- Primary completion30 Jan 2023
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detection of Type VI Secretion System in K.PneumoniaeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Saber Shafik, Sohag University
- Investigators
- Noha S Shfik, lecturer, Principal investigator, Faculty of medicine, Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516654
- Sponsor's protocol ID
- Soh-Med-22-8-23
- Acronym
- Klebsiella
- Status last verified
- Apr 2023
- First submitted
- 23 Aug 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type VI Secretion System in Klebsiella Pneumoniae Relation to Antibiotic Resistance and Biofilm Formation
- ClinicalTrials.gov ID
- NCT05516654
- Acronym / sponsor ID
- Klebsiella / Soh-Med-22-8-23
- Conditions
- Detection of Type VI Secretion System in K.Pneumoniae, Detection of Relation to Ab Resistance, Biofilm
- Keywords
- Type IV, secretion system, Klebsiella Pneumoniae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 25 Aug 2022 (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.
Klebsiella pneumoniae (K. pneumoniae) is an important opportunistic pathogen contributing to nosocomial and antimicrobial-resistant infections. The increasing prevalence of infections caused by multidrug-resistant K. pneumoniae has emerged as a major clinical and public health threat, while the serous organ and life-threatening infections caused by highly virulent K. pneumoniae have also emerged( Russo and Marr, 2019; Wyres et al., 2020).
Detailed description
Both drug-resistant and highly virulent K. pneumoniae have brought major challenges to clinical treatment and stimulated interest in studying K. pneumoniae. However, knowledge of the genomics, ecology, and pathogenicity of K. pneumoniae is relatively limited. Recently, the type VI secretion system (T6SS) was identified as a virulence factor in K. pneumoniae (Martin and Bachman, 2018). Furthermore, K. pneumoniae was found to exploit the T6SS nano-weapon to destroy bacterial competitors and fungi (Storey et al., 2020).
The bacterial Type VI Secretion System (T6SS) is a membrane-attached contractile phage tail that is physically and Mechanistically similar to a membrane-linked intracellular contractile phage tail. T6SS spike and tube elements, as well as anti-bacterial and anti-eukaryotic effectors, are propelled out of predatory T6SS positive cells and into target cells by a fast conformational shift in the structural framework of a sheath protein complex, according to recent research (Kudryashev et al., 2015).
However, the limited studies and lack of information on the T6SS in K. pneumoniae necessitate further exploration to clarify the physiological metabolism and pathogenic information of this clinically important bacterial species.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 weeks to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -Samples(pus, urine, blood, peritoneal fluid) will be collected from different departments at Sohag university hospital. Clinical Data will be obtained as: 1. Data about clinical manifestations including fever, expectoration, pus from wounds, and diarrhea, urinary symptoms, symptoms of upper respiratory tract infections, symptoms of spontaneous bacterial peritonitis. 2. Laboratory investigation: A-CBC B - CRP C- urine analysis D- serum creatinine E - Serum bilirubin F- ALT G -AST 3. Routine bacteriological cultures will be done. 4. Automated identification of the organism and antibiotic sensitivity will be done by VITEK II. 5. Biofilm formation to the collected organism by tissue culture plate method. 6. Molecular detection of Type VI Secretion System genes ,capsular serotyping( k1, k2) and FimH genes by PCR.
Key inclusion criteria (1 listed)
- All patients suffering from infections that can be caused by Klebsiella Pneumoniae.
Key exclusion criteria (1 listed)
- Samples diagnosed to have organisms other than Klebsiella Pneumoniae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine bacteriological culturesculture of different samples on different culture media as nutrient agar, blood agar, MacConkey agar, EMB agar, TSI | Diagnostic test | – |
| Identification of the organism and antibiotic sensitivity will be done by VITEK IIAutomated identification of the organism and antibiotic sensitivity will be done by VITEK II | Diagnostic test | – |
| Detection of biofilm formationDetection of Biofilm formation to the collected organism by tissue culture plate method. | Diagnostic test | – |
| Molecular detection by PCRMolecular detection of Type VI Secretion System genes, capsular serotyping( k1, k2), and FimH genes by PCR. | Diagnostic test | – |
Primary outcome
Isolation and identification of Klebsiella Pneumoniae isolated from different samples and determination of their antibiotics profile
Time frame: 1 september 2022 to 1 November 2022
Detection of Type VI Secretion System In Klebsiella Pneumoniae and its relation to Antibiotic Resistance and biofilm formation
Time frame: 2 November 2022 to February 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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.
Noha S Shfik, lecturer principal investigator
Faculty of medicine, Sohag 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 Detection of Type VI Secretion System in K.Pneumoniae and Detection of Relation to Ab Resistance, Biofilm, 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 12 Apr 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation and identification of Klebsiella Pneumoniae isolated from different samples and determination of their antibiotics profile (time frame: 1 september 2022 to 1 November 2022). 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 12 Apr 2023.