- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828550
Detection of Efflux Pump Genes Mediating Ciprofloxacin Resistance in Staphylococcus Aureus Isolates in Sohag University Hospitals
April 13, 2023 updated by: Esraa Esaam Eldin Farrag, Sohag University
Among multidrug-resistant bacteria, Methicillin-resistant Staphylococcus aureus (MRSA) isolates were recognized to be an important mortality factor in hospital infections and a major concern in health-care and community settings .
The antibiotic-resistant of S. aureus is extended by various bacterial strategies, including limiting uptake of the drug, alteration of the drugtargets, production of druginactivating enzymes and the activation of efflux pumps that effectively remove antibiotics .
Relying on the type of antibiotics, bacteria can apply one or more strategies.
Specifically, localization of resistance genes in transferable genetic elements, such as plasmid and transposons , causing Horizontal transfer of resistance genes between bacterial strains .
MRSA strains are resistant to nearly all beta-lactam antibiotics by producing an alternative penicillin-binding protein known as PBP2a .
This protein is encoded by the mecA gene and has a low affinity to manybeta-lactam antibiotics.
Furthermore, these strains often show resistance to a wide range of antibiotics .
The use of fluoroquinolone for the effective infectious therapy is limited by presence of fluoroquinolone resistance .
There are two mechanisms causing resistance to fluoroquinolone.
The first one is attributed to mutations occurring in the quinolone-resistance determining region (QRDR) of topoisomerase IV encoded by grlA/grlB and DNA gyrase encoded by gyrA/gyrB; these mutations decrease the affinity ofthe drug.
The other mechanism is mediated by efflux pumps which is less recognized .
Recently, several efflux pumps have been identified for S. aureus including efflux pumps encoded by chromosome or plasmids.
The efflux pumps norA, norB, norC, mdeA, sepA, mepA, sdrM and lmrS are encoded by chromosome while qacA/B, qacG, qacH, qacJ and smr are plasmid-encoded .
Efflux pumps could be specialized for specific substrate or mobilized a wide varieties of different antibiotic classes .
Despite, efflux pumps can potentially increase resistance to antibiotics in clinical isolates of S. aureus, few studies have been evaluated the individual and collective participation of the efflux system in resistant isolates .
Therefore the aim of the study is to detect ciprofloxacin resistant strains of staphylococcus aureus isolates and to detect efflux pump genes ( norA , norB and norC ) mediating resistance in such strains.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: esraa e farag, demonstrator
- Phone Number: 01090926328
- Email: esraaesam@med.sohag.edu.eg
Study Contact Backup
- Name: asmaa n thabet, Assistant professor
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Infections caused by S.aureus like skin infections , chest infections , surgical site infections , and urinary tract Infections
Exclusion Criteria:
- Infections caused by any organisms other than S.aureus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ciprofloxacin Resistance in Staphylococcal strains isolated
Time Frame: 6 months
|
resistance pattern of the isolates will be detected by disc diffusion method
|
6 months
|
presence of Efflux pump genes ( norA , norB , norC ) mediating Resistance in such strains
Time Frame: 6 months
|
Detection of efflux pump genes responsible for the resistance ( norA , norB , norC ) by PCR
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Havaei S, Moghadam SO, Pourmand M, Faghri J. Prevalence of Genes Encoding Bi-Component Leukocidins among Clinical Isolates of Methicillin Resistant Staphylococcus aureus. Iran J Public Health. 2010;39(1):8-14. Epub 2010 Mar 31.
- Lowy FD. Antimicrobial resistance: the example of Staphylococcus aureus. J Clin Invest. 2003 May;111(9):1265-73. doi: 10.1172/JCI18535. No abstract available.
- Pourmand MR, Yousefi M, Salami SA, Amini M. Evaluation of expression of NorA efflux pump in ciprofloxacin resistant Staphylococcus aureus against hexahydroquinoline derivative by real-time PCR. Acta Med Iran. 2014;52(6):424-9.
- Yilmaz ES, Aslantas O. Antimicrobial resistance and underlying mechanisms in Staphylococcus aureus isolates. Asian Pac J Trop Med. 2017 Nov;10(11):1059-1064. doi: 10.1016/j.apjtm.2017.10.003. Epub 2017 Nov 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2023
Primary Completion (Anticipated)
November 1, 2023
Study Completion (Anticipated)
November 1, 2023
Study Registration Dates
First Submitted
April 13, 2023
First Submitted That Met QC Criteria
April 13, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 13, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-04-01MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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