Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
NCT05287438 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2022-03-18
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.
Conditions
- Penile Implantation
- Infections
Interventions
- 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
- DIAGNOSTIC_TEST
-
Standard Culture
Standard of care culture and sensitivity
Sponsors & Collaborators
-
MicroGenDX
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-27
- Primary Completion
- 2023-10-31
- Completion
- 2024-10-31
Countries
- United States
Study Locations
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