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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Culture | Active Comparator | Following local standard of care, treatment will be based on standard culture |
|
| Group B - NGS | Experimental | Treatment will be based on NGS results reviewed by an infectious disease doctor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WK Advanced Urology | Recruiting | Bossier City | Louisiana | 71111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30707308 | Background | 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. | |
| 30671142 | 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. |
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There is no plan to share data with other researchers
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Group A will receive results based on standard culture and Group B will receive results based on NGS
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|
| Standard Culture | Diagnostic Test | Standard of care culture and sensitivity |
|
| Duke University | Recruiting | Raleigh | North Carolina | 27609 | United States |
|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| 32015525 | 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. |
| 31519461 | 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. |
| 30017899 | 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. |
| 23148447 | 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. |
| 26739158 | 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. |
| 25586931 | 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. |
| ID | Term |
|---|---|
| D007239 | Infections |
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