Antibiogram and Biofilm Formation of Bacteria Causing Pro... | NCT05239312

Studies
Antibiogram and Biofilm Formation of Bacteria Causing Prosthetic Joint Infections Isolated From Assiut University Hospital

NCT05239312

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 14, 2022Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Prosthetic Joint Infection

Interventions

Antimicrobial

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2022Estimated

Primary Completion Date

Mar 2024Estimated

Completion Date

May 2024Estimated

First Submitted Date

Nov 14, 2021

First Submission Date that Met QC Criteria

Feb 3, 2022

First Posted Date

Feb 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2022

Last Update Posted Date

Feb 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amina Abd El Aal Mohammed Abd El Aal Makhlouf, Assistant lecturer, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Setting of antibiogram in orthopedic department
Evaluate the production of biofilm in bacteria isolated from specimens phenotypically and genotypically.

Detailed Description

Increased use of total joint arthroplasties will naturally result in a related increase in the number of prosthetic joint infections (PJIs).

PJI is a disastrous complication of orthopedic surgery, frequently leading to prolonged morbidity and increased mortality. Moreover, therapy for PJI is associated with enormous costs.

PJI results from numerous factors that lead to inability of periprosthetic immune cells to protect implant surfaces and tissues from bacterial colonization.

The most destabilizing factor is the ability of bacteria to adhere to and survive on virtually all natural and synthetic surfaces.

Once firmly attached to the surface of an implant, the microorganisms initiate "biofilm" formation, which is a complex of microbial cells embedded in an extracellular matrix composed of proteins, extracellular DNA, and exopolysaccharides, providing protection for bacteria and making them extremely resistant to the immune system and antibiotic.

An ineffective empiric antibiotic regimen can be harmful to patients while unnecessary broad-spectrum antibiotics lead to increased resistance. However, healthcare providers often select an antibiotic regimen before bacterial antibiotic sensitivities are available.

The Clinical and Laboratory of Standards Institute publishes the M39 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline, which is a referenced guideline on how to create antibiograms.

The antibiogram has multiple uses, including providing guidance for empiric antibiotic therapy, monitoring changes in resistance over time, assisting in formulary decisions and supports antimicrobial stewardship programs to reduce multidrug resistant organisms and the risks of adverse drug events.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with prosthetic joint infection			Drug: Antimicrobial

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antimicrobial	Drug	Implementation of antimicrobial protocol for empirical treatment which will be done according to the results of antibiotic susceptibility	Patients with prosthetic joint infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibiogram for PJI	Percentages of different bacterial species causing prosthetic joint infection and their Antimicrobial sensitivity pattern.	18 months

Secondary Outcomes

Measure	Description	Time Frame
Biofilm formation	Percentage of different bacteria responsible for biofilm formation	18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:
- Age above 18 years old
- no intraarticular surgery of the respective joint prior to the index surgery.
Exclusion criteria:
- Age below 18 years old
- If the patient had any intraarticular surgery prior to the primary arthroplasty in the respective joint.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study will be conducted on 90 informed individuals (according to guidelines of ethical committee of faculty of medicine , Assuit University )

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amina Abd El Aal Mohammed	Contact	01006956223		amina.makhlouf.26@gmail.com
Hebat Allah G. Rashed	Contact	01003997231		hebager@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32664491	Background	Gallo J, Nieslanikova E. Prevention of Prosthetic Joint Infection: From Traditional Approaches towards Quality Improvement and Data Mining. J Clin Med. 2020 Jul 11;9(7):2190. doi: 10.3390/jcm9072190.
31555507	Background	Fischbacher A, Borens O. Prosthetic-joint Infections: Mortality Over The Last 10 Years. J Bone Jt Infect. 2019 Sep 17;4(4):198-202. doi: 10.7150/jbji.35428. eCollection 2019.

ID	Term
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses