NCT05828550

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

April 13, 2023

Last Update Submit

July 8, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ciprofloxacin Resistance in Staphylococcal strains isolated

    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

    Detection of efflux pump genes responsible for the resistance ( norA , norB , norC ) by PCR

    6 months

Interventions

antibiotic sensitivityDIAGNOSTIC_TEST

The resistance pattern of the isolates will be detected by disc diffusion method. Detection of efflux pump genes responsible for the resistance ( norA , norB , norC ) by PCR

Also known as: polymerase chain reaction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Infections caused by S.aureus like skin infections , chest infections , surgical site infections , and urinary tract Infections

You may not qualify if:

  • Infections caused by any organisms other than S.aureus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Sohag Governorate, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 23112984BACKGROUND
  • 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.

    PMID: 12727914BACKGROUND
  • 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.

    PMID: 25130148BACKGROUND
  • 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.

    PMID: 29203102BACKGROUND

MeSH Terms

Conditions

Surgical Wound InfectionUrinary Tract Infections

Interventions

Drug Collateral Sensitivity

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug InteractionsPharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonestrator at microbiology and Immunology department

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 25, 2023

Study Start

May 1, 2023

Primary Completion

November 23, 2023

Study Completion

November 30, 2024

Last Updated

July 11, 2025

Record last verified: 2025-07

Locations