Comparison of Standard of Care Guidelines for Mycoplasma... | NCT03910907

Studies
Comparison of Standard of Care Guidelines for Mycoplasma Genitalium Infections Among Men With Non-gonococcal Urethritis

NCT03910907

Sponsor

University of Alabama at Birmingham

Status

Terminated

Last Update Posted

Jun 2, 2023Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Mycoplasma Genitalium Infection

Interventions

Comparison of two standard of care regimens

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Covid

Expanded Access Info

Start Date

Nov 19, 2019Actual

Primary Completion Date

Mar 20, 2020Actual

Completion Date

Mar 20, 2020Actual

First Submitted Date

Apr 8, 2019

First Submission Date that Met QC Criteria

Apr 8, 2019

First Posted Date

Apr 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2023

Last Update Posted Date

Jun 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Barbara Van Der Pol, Primary Investigator, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Mycoplasma genitalium (MG) has been associated with non-gonococcal urethritis (NGU) in many populations and the prevalence of MG strains with macrolide-resistance associated gene mutations is increasing . While no MG diagnostic assays have FDA clearance in the United States (US), treatment for NGU is primarily focused on managing potential infection with Chlamydia trachomatis (CT) using single dose 1 gm Azithromycin (a macrolide class of drug). Without testing for MG that might alter NGU treatment strategies, the current paradigm may be contributing to selective pressure resulting in increased macrolide resistance in MG. In Australia, awareness of the prevalence of MG and macrolide resistance-associated mutations has been facilitated by an approved diagnostic test manufactured by SpeeDx. Ltd. As a result of the epidemiologic information generated by this diagnostic tool [MG ResistancePlus (MRP) Assay], the Australian Sexual Health Alliance, who publish the Australian Sexually Transmitted Infection (STI) Management Guidelines for Use in Primary Care, have revised the management of men with NGU and MG infection. The new management guidelines include initial treatment of NGU with doxycycline, and concomitant testing for MG and macrolide resistance, with subsequent treatment for MG infected patients according to resistance results. We propose using the MRP assay in a population of men with NGU to determine the clinical impact of the Australian treatment strategy compared to the current standard of care for NGU on clearance of MG infection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Comparison of two standard of care regimens	Drug	Treatment according to results of laboratory detection of resistance markers	Standard of care Standard of care plus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants with Molecular Clearance	DNA negative for mycoplasma	90 days

Secondary Outcomes

Measure	Description	Time Frame
Positive Participants with Macrolide-Resistant Mycoplasma	DNA positive for macrolide-resistant mycoplasma	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-English speaking

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Men with non-gonoccocal

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara Van Der Pol, PhD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UAB		Birmingham	Alabama	35294	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014526	Urethritis

Ancestor Terms

ID	Term
D014522	Urethral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided