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

March 10, 2022 updated by: MicroGenDX
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Recruiting
        • WK Advanced Urology
        • Contact:
        • Principal Investigator:
          • Gerard Henry, MD
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Aaron Lentz, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Paul Chung, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A - Culture
Following local standard of care, treatment will be based on standard culture
Diagnostic test: Standard Culture
Standard of care culture and sensitivity
EXPERIMENTAL: Group B - NGS
Treatment will be based on NGS results reviewed by an infectious disease doctor
Diagnostic test: Next-Generation DNA Sequencing
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
Other Names:
  • NGS

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroGenDX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 27, 2021

Primary Completion (ANTICIPATED)

October 31, 2023

Study Completion (ANTICIPATED)

October 31, 2024

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (ACTUAL)

March 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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