NCT05239312

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Status
unknown

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

November 14, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

November 14, 2021

Last Update Submit

February 3, 2022

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

  • Antibiogram for PJI

    Percentages of different bacterial species causing prosthetic joint infection and their Antimicrobial sensitivity pattern.

    18 months

Secondary Outcomes (1)

  • Biofilm formation

    18 months

Study Arms (1)

Patients with prosthetic joint infection

Drug: Antimicrobial

Interventions

AntimicrobialDRUG

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

Also known as: Implementation of infection prevention and control policies
Patients with prosthetic joint infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age above 18 years old
  • no intraarticular surgery of the respective joint prior to the index surgery.

You may not qualify if:

  • Age below 18 years old
  • If the patient had any intraarticular surgery prior to the primary arthroplasty in the respective joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 32664491BACKGROUND

  • 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.

    PMID: 31555507BACKGROUND

  • 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.

    PMID: 30642705BACKGROUND

  • 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.

    PMID: 31524584BACKGROUND

  • 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.

    PMID: 31333180BACKGROUND

  • 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.

    PMID: 30938200BACKGROUND

  • 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.

    PMID: 31754470BACKGROUND

  • 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.

    PMID: 29720707BACKGROUND

  • 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.

    PMID: 27386527BACKGROUND

  • 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.

    PMID: 31548277BACKGROUND

  • 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.

    PMID: 20733044BACKGROUND

  • 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.

    PMID: 18359426BACKGROUND

  • 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.

    PMID: 33996074BACKGROUND

  • 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.

    PMID: 25133863BACKGROUND

MeSH Terms

Interventions

Anti-Infective Agents

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Amina Abd El Aal Mohammed

CONTACT

01006956223amina.makhlouf.26@gmail.com

Hebat Allah G. Rashed

CONTACT

01003997231hebager@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

November 14, 2021

First Posted

February 14, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

February 14, 2022

Record last verified: 2022-02