Prosthetic Joint InfectionNCT05239312
Antibiogram and Biofilm Formation of Bacteria Causing Prosthetic Joint Infections Isolated From Assiut University Hospital
An observational study of Prosthetic Joint Infection, run by Assiut University.
Trial summary
1. Setting of antibiogram in orthopedic department 2. Evaluate the production of biofilm in bacteria isolated from specimens phenotypically and genotypically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- Antimicrobial
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted on 90 informed individuals (according to guidelines of ethical committee of faculty of medicine , Assuit University )
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
- Setting of antibiogram in orthopedic department
- Evaluate the production of biofilm in bacteria isolated from specimens phenotypically and genotypically.
Read the 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.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Antimicrobial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntimicrobialDrug
Also called Implementation of infection prevention and control policies
Implementation of antimicrobial protocol for empirical treatment which will be done according to the results of antibiotic susceptibility
| Study group | Role | What they receive |
|---|---|---|
| Patients with prosthetic joint infection | Not described Receives: Drug: Antimicrobial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiogram for PJI
Percentages of different bacterial species causing prosthetic joint infection and their Antimicrobial sensitivity pattern.
Measured: 18 months
Secondary outcomes (1)
Biofilm formation
Percentage of different bacteria responsible for biofilm formation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amina Abd El Aal Mohammed Abd El Aal Makhlouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239312
- Sponsor's protocol ID
- Antibiogram and biofilm in PJI
- Status last verified
- Feb 2022
- First submitted
- 14 Nov 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32664491Fischbacher 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.
PubMed 31555507Natsuhara 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.
PubMed 30642705Musil 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.
PubMed 31524584Musil 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.
PubMed 31333180Puhto 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.
PubMed 30938200Davidson 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.
PubMed 31754470Arciola 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.
PubMed 29720707Baker 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.
PubMed 27386527Orazi 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.
PubMed 31548277Paul 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.
PubMed 20733044Kuti 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.
PubMed 18359426Klinker 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.
PubMed 33996074Mitchell 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.
PubMed 25133863
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiogram and Biofilm Formation of Bacteria Causing Prosthetic Joint Infections Isolated From Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05239312
- Acronym / sponsor ID
- Antibiogram and biofilm in PJI
- Conditions
- Prosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with prosthetic joint infection | – | Drug: Antimicrobial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted on 90 informed individuals (according to guidelines of ethical committee of faculty of medicine , Assuit University )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntimicrobialAlso: Implementation of infection prevention and control policiesImplementation of antimicrobial protocol for empirical treatment which will be done according to the results of antibiotic susceptibility | Drug | Patients with prosthetic joint infection |
Primary outcome
Antibiogram for PJI
Time frame: 18 months
Percentages of different bacterial species causing prosthetic joint infection and their Antimicrobial sensitivity pattern.
1 secondary outcome
Biofilm formation
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 32664491Gallo 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.
- Background: PubMed 31555507Fischbacher 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.
- Background: PubMed 30642705Natsuhara 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.
- Background: PubMed 31524584Musil 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.
- Background: PubMed 31333180Musil 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.
- Background: PubMed 30938200Puhto 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.
- Background: PubMed 31754470Davidson 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.
- Background: PubMed 29720707Arciola 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.
- Background: PubMed 27386527Baker 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.
- Background: PubMed 31548277Orazi 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.
- Background: PubMed 20733044Paul 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.
- Background: PubMed 18359426Kuti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic Joint Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amina Abd El Aal Mohammed (01006956223, amina.makhlouf.26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiogram for PJI (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05239312, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.