Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
NCT ID: NCT05287438
Last Updated: 2022-03-18
Study Results
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-10-27
2024-10-31
Brief Summary
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Detailed Description
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Subjects will be randomized into the culture arm or the NGS arm. If randomized to NGS: central ID reviews result according to arm and offers recommendations. Physician will treat based on antibiotic recommendations (based on positive PCR/NGS or positive culture, if negative then empiric treatment will be continued) adjusted for patients contraindications and co-morbidities If randomized to the traditional culture arm: Physician will follow routine local standard of care.
A follow-up visit will occur within 10 days of starting empiric antibiotic therapy to collect symptoms scoring questionnaire. A 2nd and final visit will occur 6 months after baseline to collect similar data to the 1st follow up visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group A - Culture
Following local standard of care, treatment will be based on standard culture
Standard Culture
Standard of care culture and sensitivity
Group B - NGS
Treatment will be based on NGS results reviewed by an infectious disease doctor
Next-Generation DNA Sequencing
NGS is a technique of microbiological sequencing, using 16s ribosomal RNA molecular identification has been implemented to detect bacteria and fungi present in the sample
Interventions
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Next-Generation DNA Sequencing
NGS is a technique of microbiological sequencing, using 16s ribosomal RNA molecular identification has been implemented to detect bacteria and fungi present in the sample
Standard Culture
Standard of care culture and sensitivity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age range: 18-80
* Within 6 months of penile prosthesis surgery
* At least 1 of the following: Device part stuck to thinning skin, any drainage from the wound site, massive red and swollen genitalia parts, exposed penile prosthesis parts, draining open tract, draining hematoma
Exclusion Criteria
* Not able to communicate or follow up well, or non-compliant
* Less than 18 or more than 80 years old
* Active addiction
* Main issue is implant pain
18 Years
80 Years
MALE
No
Sponsors
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MicroGenDX
INDUSTRY
Responsible Party
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Locations
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WK Advanced Urology
Bossier City, Louisiana, United States
Duke University
Raleigh, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Facility Contacts
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References
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Carrasquillo RJ, Munarriz RM, Gross MS. Infection Prevention Considerations for Complex Penile Prosthesis Recipients. Curr Urol Rep. 2019 Feb 1;20(3):12. doi: 10.1007/s11934-019-0875-7.
Krzastek SC, Smith R. An update on the best approaches to prevent complications in penile prosthesis recipients. Ther Adv Urol. 2019 Jan 8;11:1756287218818076. doi: 10.1177/1756287218818076. eCollection 2019 Jan-Dec.
Carvajal A, Benavides J, Garcia-Perdomo HA, Henry GD. Risk factors associated with penile prosthesis infection: systematic review and meta-analysis. Int J Impot Res. 2020 Nov;32(6):587-597. doi: 10.1038/s41443-020-0232-x. Epub 2020 Feb 3.
Mahon J, Dornbier R, Wegrzyn G, Faraday MM, Sadeghi-Nejad H, Hakim L, McVary KT. Infectious Adverse Events Following the Placement of a Penile Prosthesis: A Systematic Review. Sex Med Rev. 2020 Apr;8(2):348-354. doi: 10.1016/j.sxmr.2019.07.005. Epub 2019 Sep 10.
Carrasquillo RJ, Gross MS. Infection Prevention Strategies Prior to Penile Implant Surgery. Eur Urol Focus. 2018 Apr;4(3):317-320. doi: 10.1016/j.euf.2018.07.002. Epub 2018 Jul 13.
Levy PY, Fenollar F. The role of molecular diagnostics in implant-associated bone and joint infection. Clin Microbiol Infect. 2012 Dec;18(12):1168-75. doi: 10.1111/1469-0691.12020.
Salimnia H, Fairfax MR, Lephart PR, Schreckenberger P, DesJarlais SM, Johnson JK, Robinson G, Carroll KC, Greer A, Morgan M, Chan R, Loeffelholz M, Valencia-Shelton F, Jenkins S, Schuetz AN, Daly JA, Barney T, Hemmert A, Kanack KJ. Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial. J Clin Microbiol. 2016 Mar;54(3):687-98. doi: 10.1128/JCM.01679-15. Epub 2016 Jan 6.
Tzeng A, Tzeng TH, Vasdev S, Korth K, Healey T, Parvizi J, Saleh KJ. Treating periprosthetic joint infections as biofilms: key diagnosis and management strategies. Diagn Microbiol Infect Dis. 2015 Mar;81(3):192-200. doi: 10.1016/j.diagmicrobio.2014.08.018. Epub 2014 Nov 5.
Other Identifiers
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MDX-002
Identifier Type: -
Identifier Source: org_study_id
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