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

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ClinicalTrials.gov Identifier: NCT03910907
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Barbara Van Der Pol, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment
Mycoplasma Genitalium Infection Drug: Comparison of two standard of care regimens

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Current Standard of Care Versus the Australian Guidelines for Management of Mycoplasma Genitalium Infections Among Men Being Treated for Non-gonococcal Urethritis
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2021

Group/Cohort Intervention/treatment
Standard of care
Men treated for mycoplasma according to standard of care
Drug: Comparison of two standard of care regimens
Treatment according to results of laboratory detection of resistance markers

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
Treatment according to results of laboratory detection of resistance markers




Primary Outcome Measures :
  1. Participants with Molecular Clearance [ Time Frame: 90 days ]
    DNA negative for mycoplasma


Secondary Outcome Measures :
  1. Positive Participants with Macrolide-Resistant Mycoplasma [ Time Frame: 90 days ]
    DNA positive for macrolide-resistant mycoplasma


Biospecimen Retention:   Samples With DNA
Residual urine samples will be retained


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with non-gonoccocal
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910907


Contacts
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Contact: Charles A Rivers, PhD 205-996-4023 rivers@uab.edu

Locations
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United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Barbara Van Der Pol, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Barbara Van Der Pol, PhD University of Alabama at Birmingham

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Responsible Party: Barbara Van Der Pol, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03910907    
Other Study ID Numbers: IRB-300003178
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Barbara Van Der Pol, University of Alabama at Birmingham:
mycoplasma genitalium
urethritis
NGU
treatment
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Mycoplasma Infections
Pleuropneumonia
Urethritis
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Urethral Diseases
Urologic Diseases