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

NCT ID: NCT05239312

Last Updated: 2022-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-31

Study Completion Date

2024-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prosthetic Joint Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with prosthetic joint infection

Antimicrobial

Intervention Type DRUG

Implementation of antimicrobial protocol for empirical treatment which will be done according to the results of antibiotic susceptibility

Interventions

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Antimicrobial

Implementation of antimicrobial protocol for empirical treatment which will be done according to the results of antibiotic susceptibility

Intervention Type DRUG

Other Intervention Names

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Implementation of infection prevention and control policies

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amina Abd El Aal Mohammed Abd El Aal Makhlouf

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amina Abd El Aal Mohammed

Role: CONTACT

01006956223

Hebat Allah G. Rashed

Role: CONTACT

01003997231

References

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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.

Reference Type BACKGROUND
PMID: 32664491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31555507 (View on PubMed)

Natsuhara KM, Shelton TJ, Meehan JP, Lum ZC. Mortality During Total Hip Periprosthetic Joint Infection. J Arthroplasty. 2019 Jul;34(7S):S337-S342. doi: 10.1016/j.arth.2018.12.024. Epub 2018 Dec 24.

Reference Type BACKGROUND
PMID: 30642705 (View on PubMed)

Musil D, Snorek M, Gallo J, Jahoda D, Stehlik J. [Economic Analysis of the Costs of Hospital Stay of Patients with Infection as a Complication of Total Replacements - Part 2: Total Hip Arthroplasty]. Acta Chir Orthop Traumatol Cech. 2019;86(4):241-248. Czech.

Reference Type BACKGROUND
PMID: 31524584 (View on PubMed)

Musil D, Snorek M, Gallo J, Jahoda D, Stehlik J. [Economic Analysis of the Costs of Hospital Stay of Patients with Infection as a Complication of Total Replacements - Part 1: Total Knee Arthroplasty]. Acta Chir Orthop Traumatol Cech. 2019;86(3):173-180. Czech.

Reference Type BACKGROUND
PMID: 31333180 (View on PubMed)

Puhto T, Puhto AP, Vielma M, Syrjala H. Infection triples the cost of a primary joint arthroplasty. Infect Dis (Lond). 2019 May;51(5):348-355. doi: 10.1080/23744235.2019.1572219. Epub 2019 Apr 2.

Reference Type BACKGROUND
PMID: 30938200 (View on PubMed)

Davidson DJ, Spratt D, Liddle AD. Implant materials and prosthetic joint infection: the battle with the biofilm. EFORT Open Rev. 2019 Nov 5;4(11):633-639. doi: 10.1302/2058-5241.4.180095. eCollection 2019 Nov.

Reference Type BACKGROUND
PMID: 31754470 (View on PubMed)

Arciola CR, Campoccia D, Montanaro L. Implant infections: adhesion, biofilm formation and immune evasion. Nat Rev Microbiol. 2018 Jul;16(7):397-409. doi: 10.1038/s41579-018-0019-y.

Reference Type BACKGROUND
PMID: 29720707 (View on PubMed)

Baker P, Hill PJ, Snarr BD, Alnabelseya N, Pestrak MJ, Lee MJ, Jennings LK, Tam J, Melnyk RA, Parsek MR, Sheppard DC, Wozniak DJ, Howell PL. Exopolysaccharide biosynthetic glycoside hydrolases can be utilized to disrupt and prevent Pseudomonas aeruginosa biofilms. Sci Adv. 2016 May 20;2(5):e1501632. doi: 10.1126/sciadv.1501632. eCollection 2016 May.

Reference Type BACKGROUND
PMID: 27386527 (View on PubMed)

Orazi G, O'Toole GA. "It Takes a Village": Mechanisms Underlying Antimicrobial Recalcitrance of Polymicrobial Biofilms. J Bacteriol. 2019 Dec 6;202(1):e00530-19. doi: 10.1128/JB.00530-19. Print 2019 Dec 6.

Reference Type BACKGROUND
PMID: 31548277 (View on PubMed)

Paul M, Shani V, Muchtar E, Kariv G, Robenshtok E, Leibovici L. Systematic review and meta-analysis of the efficacy of appropriate empiric antibiotic therapy for sepsis. Antimicrob Agents Chemother. 2010 Nov;54(11):4851-63. doi: 10.1128/AAC.00627-10. Epub 2010 Aug 23.

Reference Type BACKGROUND
PMID: 20733044 (View on PubMed)

Kuti EL, Patel AA, Coleman CI. Impact of inappropriate antibiotic therapy on mortality in patients with ventilator-associated pneumonia and blood stream infection: a meta-analysis. J Crit Care. 2008 Mar;23(1):91-100. doi: 10.1016/j.jcrc.2007.08.007.

Reference Type BACKGROUND
PMID: 18359426 (View on PubMed)

Klinker KP, Hidayat LK, DeRyke CA, DePestel DD, Motyl M, Bauer KA. Antimicrobial stewardship and antibiograms: importance of moving beyond traditional antibiograms. Ther Adv Infect Dis. 2021 May 5;8:20499361211011373. doi: 10.1177/20499361211011373. eCollection 2021 Jan-Dec.

Reference Type BACKGROUND
PMID: 33996074 (View on PubMed)

Mitchell SL, Shaffer ML, Loeb MB, Givens JL, Habtemariam D, Kiely DK, D'Agata E. Infection management and multidrug-resistant organisms in nursing home residents with advanced dementia. JAMA Intern Med. 2014 Oct;174(10):1660-7. doi: 10.1001/jamainternmed.2014.3918.

Reference Type BACKGROUND
PMID: 25133863 (View on PubMed)

Other Identifiers

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Antibiogram and biofilm in PJI

Identifier Type: -

Identifier Source: org_study_id

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