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

MicroGenDX

Status: Enrolling

Conditions: Penile Implantation; Infections

Treatments: Diagnostic Test: Next-Generation DNA Sequencing; Diagnostic Test: Standard Culture

Study type: Interventional

Funder types: Industry

Identifiers

NCT05287438

MDX-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A - Culture

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Standard Culture

Group B - NGS

Experimental group

Description:

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

Treatment:

Diagnostic Test: Next-Generation DNA Sequencing