Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes

NCT05287438 | Unknown DMC

• 1 other identifier: MDX-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes.

Conditions

Penile Implantation; Infections

Keywords

next generation sequencing; penile prosthesis; infections

Outcome Measures

Primary Outcomes (2)

• Device survival rates by calculating by incidence of implant freely mobile and working without tenderness

  To determine if device survival rates outcomes are improved using NGS versus traditional culture

  2 years

• Patient satisfaction of penile prosthesis

  Satisfaction is a 5-point descriptive scale in which subjects self-report that degree of satisfaction: high, mostly, fair, minimum, and none

  2 years

Study Arms (2)

Group A - Culture

ACTIVE COMPARATOR

Following local standard of care, treatment will be based on standard culture

Diagnostic Test: Standard Culture

Group B - NGS

EXPERIMENTAL

Treatment will be based on NGS results reviewed by an infectious disease doctor

Diagnostic Test: Next-Generation DNA Sequencing

Interventions

Next-Generation DNA Sequencing DIAGNOSTIC_TEST

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

Also known as: NGS

Group B - NGS

Standard Culture DIAGNOSTIC_TEST

Standard of care culture and sensitivity

Group A - Culture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male penile prosthesis patients
• 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

You may not qualify if:

• Transgender / neophallus
• 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

Sponsors & Collaborators

• MicroGenDX: lead

Study Sites (3)

WK Advanced Urology

Bossier City, Louisiana, 71111, United States

RECRUITING

Duke University

Raleigh, North Carolina, 27609, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 30707308 BACKGROUND

• 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.

  PMID: 30671142 BACKGROUND

• 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.

  PMID: 32015525 BACKGROUND

• 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.

  PMID: 31519461 BACKGROUND

• 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.

  PMID: 30017899 BACKGROUND

• 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.

  PMID: 23148447 BACKGROUND

• 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.

  PMID: 26739158 BACKGROUND

• 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.

  PMID: 25586931 BACKGROUND

MeSH Terms

Conditions

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group A will receive results based on standard culture and Group B will receive results based on NGS

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 18, 2022
• Study Start: October 27, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2024
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)