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Penile ImplantationNCT05287438

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

A study testing Next-Generation DNA Sequencing and Standard Culture in people with Penile Implantation and Infections, run by MicroGenDX at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Penile Implantation, Infections
What is being tested?
Next-Generation DNA Sequencing and Standard Culture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
27 Oct 2021to 31 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

United States3 sites, 3 recruiting

  • WK Advanced Urology

    Bossier City, Louisiana, 71111

    Ryan Griggs, MD, 318-212-7335, rpgriggsuro@gmail.com

    Gerard Henry, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Paul Chung, MD, 215-955-1000, paul.chung@jefferson.edu

    Paul Chung, MD

    Recruiting

  • Duke University

    Raleigh, North Carolina, 27609

    Adi Molvin, RN, BSN, 919-681-4990, adi.molvin@dule.edu

    Aaron Lentz, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Next-Generation DNA Sequencing, Standard Culture
Keywords
next generation sequencing, penile prosthesis, infections
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Next-Generation DNA SequencingDiagnostic test

    Also called NGS

    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

  • Standard CultureDiagnostic test

    Standard of care culture and sensitivity

Study groups in NCT05287438
Study groupRoleWhat they receive
Group A - CultureActive comparatorFollowing local standard of care, treatment will be based on standard culture
Receives: Diagnostic Test: Standard Culture
Group B - NGSExperimentalTreatment will be based on NGS results reviewed by an infectious disease doctor
Receives: Diagnostic Test: Next-Generation DNA Sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

  2. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start27 Oct 2021
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A will receive results based on standard culture and Group B will receive results based on NGS
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05287438
Sponsor's protocol ID
MDX-002
Status last verified
Mar 2022
First submitted
2 Mar 2022
Last updated
18 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share data with other researchers

Publications

  • Carrasquillo RJ, Munarriz RM, Gross MS. Infection Prevention Considerations for Complex Penile Prosthesis Recipients. Curr Urol Rep. 2019 Feb 1;20(3):12. doi: 10.1007/s11934-019-0875-7.

    PubMed 30707308

  • Krzastek SC, Smith R. An update on the best approaches to prevent complications in penile prosthesis recipients. Ther Adv Urol. 2019 Jan 8;11:1756287218818076. doi: 10.1177/1756287218818076. eCollection 2019 Jan-Dec.

    PubMed 30671142

  • Carvajal A, Benavides J, Garcia-Perdomo HA, Henry GD. Risk factors associated with penile prosthesis infection: systematic review and meta-analysis. Int J Impot Res. 2020 Nov;32(6):587-597. doi: 10.1038/s41443-020-0232-x. Epub 2020 Feb 3.

    PubMed 32015525

  • Mahon J, Dornbier R, Wegrzyn G, Faraday MM, Sadeghi-Nejad H, Hakim L, McVary KT. Infectious Adverse Events Following the Placement of a Penile Prosthesis: A Systematic Review. Sex Med Rev. 2020 Apr;8(2):348-354. doi: 10.1016/j.sxmr.2019.07.005. Epub 2019 Sep 10.

    PubMed 31519461

  • Carrasquillo RJ, Gross MS. Infection Prevention Strategies Prior to Penile Implant Surgery. Eur Urol Focus. 2018 Apr;4(3):317-320. doi: 10.1016/j.euf.2018.07.002. Epub 2018 Jul 13.

    PubMed 30017899

  • Levy PY, Fenollar F. The role of molecular diagnostics in implant-associated bone and joint infection. Clin Microbiol Infect. 2012 Dec;18(12):1168-75. doi: 10.1111/1469-0691.12020.

    PubMed 23148447

  • Salimnia H, Fairfax MR, Lephart PR, Schreckenberger P, DesJarlais SM, Johnson JK, Robinson G, Carroll KC, Greer A, Morgan M, Chan R, Loeffelholz M, Valencia-Shelton F, Jenkins S, Schuetz AN, Daly JA, Barney T, Hemmert A, Kanack KJ. Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial. J Clin Microbiol. 2016 Mar;54(3):687-98. doi: 10.1128/JCM.01679-15. Epub 2016 Jan 6.

    PubMed 26739158

  • Tzeng A, Tzeng TH, Vasdev S, Korth K, Healey T, Parvizi J, Saleh KJ. Treating periprosthetic joint infections as biofilms: key diagnosis and management strategies. Diagn Microbiol Infect Dis. 2015 Mar;81(3):192-200. doi: 10.1016/j.diagmicrobio.2014.08.018. Epub 2014 Nov 5.

    PubMed 25586931

Questions about this trial

What is this clinical trial studying?

A study testing Next-Generation DNA Sequencing and Standard Culture in people with Penile Implantation and Infections, run by MicroGenDX at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device survival rates by calculating by incidence of implant freely mobile and working without tenderness (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05287438, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.

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