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

Not Applicable

Recruiting

• Conditions: Penile Implantation; Infections
• Interventions: Diagnostic Test: Next-Generation DNA Sequencing; Diagnostic Test: Standard Culture

• Registration Number: NCT05287438
• Lead Sponsor: MicroGenDX

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.

Study Timeline

• Study Start: 2021-10-27
• Status Verified: 2022-03
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18
• Primary Completion: 2023-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B - NGS	Next-Generation DNA Sequencing	Treatment will be based on NGS results reviewed by an infectious disease doctor
Group A - Culture	Standard Culture	Following local standard of care, treatment will be based on standard culture

Primary Outcome Measures

Name	Time	Method
Device survival rates by calculating by incidence of implant freely mobile and working without tenderness	2 years	To determine if device survival rates outcomes are improved using NGS versus traditional culture
Patient satisfaction of penile prosthesis	2 years	Satisfaction is a 5-point descriptive scale in which subjects self-report that degree of satisfaction: high, mostly, fair, minimum, and none

Trial Locations

Locations (3)

WK Advanced Urology; 🇺🇸 Bossier City, Louisiana, United States

Duke University; 🇺🇸 Raleigh, North Carolina, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States