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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

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

Conditions
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Penile Implantation, Infections

Intervention / Treatment
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* Diagnostic Test: Next-Generation DNA Sequencing
* Diagnostic Test: Standard Culture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A will receive results based on standard culture and Group B will receive results based on NGS
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A - Culture<br>Following local standard of care, treatment will be based on standard culture | Diagnostic Test: Standard Culture<br>* Standard of care culture and sensitivity<br>|
| Experimental: Group B - NGS<br>Treatment will be based on NGS results reviewed by an infectious disease doctor | Diagnostic Test: Next-Generation DNA Sequencing<br>* 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<br>* Other names: NGS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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next generation sequencing, penile prosthesis, infections