NCT03910907

Brief Summary

The purpose of this protocol is to determine the difference in clearance of Mycoplasma genitalium (MG) when using the Australian management protocol versus the current Centers of Disease Control (CDC) treatment guidelines for US standard of care (SOC), to determine the proportion of men from the Deep South, with NGU attributable to MG, and to determine the proportion of MG cases that harbor the macrolide-resistance associated with mutation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

June 2, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

April 8, 2019

Last Update Submit

June 1, 2023

Conditions

Mycoplasma Genitalium Infection

Keywords

mycoplasma genitaliumurethritisNGUtreatment

Outcome Measures

Primary Outcomes (1)

  • Participants with Molecular Clearance

    DNA negative for mycoplasma

    90 days

Secondary Outcomes (1)

  • Positive Participants with Macrolide-Resistant Mycoplasma

    90 days

Study Arms (2)

Standard of care

Men treated for mycoplasma according to standard of care

Drug: Comparison of two standard of care regimens

Standard of care plus

Men treated for mycoplasma according to standard of care with regimen selected based on laboratory detection of resistance markers

Drug: Comparison of two standard of care regimens

Interventions

Comparison of two standard of care regimensDRUG

Treatment according to results of laboratory detection of resistance markers

Standard of careStandard of care plus

Eligibility Criteria

Age18 Years - 99 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with non-gonoccocal

You may qualify if:

  • Presenting with symptoms of urethritis (dysuria and/or urethral discharge)

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual urine samples will be retained

MeSH Terms

Conditions

Urethritis

Condition Hierarchy (Ancestors)

Urethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Barbara Van Der Pol, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 10, 2019

Study Start

November 19, 2019

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

June 2, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)