Clinical trial NCT05287438: Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
Official title: Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Penile Implantation
Infections
Keywords: next generation sequencing
penile prosthesis
infections
Lead sponsor: MicroGenDX
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A will receive results based on standard culture and Group B will receive results based on NGS
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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. Eligible subjects will undergo a baseline/screening visit at which time the following will be collected: demographics/history/known allergies to antibiotics, symptom scoring questionnaire. Drainage swabs OR needle aspiration will be collected for standard culture and PCR/NGS and empiric antibiotics will start.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Device survival rates by calculating by incidence of implant freely mobile and working without tenderness
timeFrame: 2 years
measure: Patient satisfaction of penile prosthesis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bossier City
country: United States
facility: WK Advanced Urology
state: Louisiana
city: Raleigh
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.