Type VI Secretion System in Klebsiella Pneumoniae (Klebsiella)

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).

Study Overview

• Status: Recruiting
• Conditions: Detection of Type VI Secretion System in K.Pneumoniae; Detection of Relation to Ab Resistance, Biofilm
• Intervention / Treatment: Diagnostic test: Routine bacteriological cultures; Diagnostic test: Identification of the organism and antibiotic sensitivity will be done by VITEK II; Diagnostic test: Detection of biofilm formation; Diagnostic test: Molecular detection by PCR

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Recruiting
    • Faculty of medicine
    • Contact: Noha S Shafik, Lecturer; Phone Number: 00201067261504; Email: nohasaber@med.sohag.edu.eg
    • Contact: Nesma A Mohammed, Lecturer; Phone Number: 00201006780725; Email: Nesmaaateef@med.sohag.edu.eg
    • Sub-Investigator: Reem M Abd Elhamed, Lecturer
    • Sub-Investigator: Arafat M Mohammed, Lecturer
    • Sub-Investigator: Mohamed H Alrawy, Lecturer
    • Principal Investigator: Noha S Shafik, lecturer
    • Sub-Investigator: Nesma A Mohammed, Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• All patients suffering from infections that can be caused by Klebsiella Pneumoniae.

Exclusion Criteria:

• Samples diagnosed to have organisms other than Klebsiella Pneumoniae

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Isolation and identification of Klebsiella Pneumoniae isolated from different samples and determination of their antibiotics profile	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	2 November 2022 to February 2023

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Noha S Shfik, lecturer, Faculty of Medicine, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Type IV; secretion system; Klebsiella Pneumoniae
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Pneumonia; Klebsiella Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: Soh-Med-22-8-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No