Mycoplasma Genitalium InfectionNCT03910907
Comparison of Standard of Care Guidelines for Mycoplasma Genitalium Infections Among Men With Non-gonococcal Urethritis
An observational study of Mycoplasma Genitalium Infection, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Mycoplasma Genitalium Infection
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 20 Mar 2020
- Phase
- Observational
- 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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with non-gonoccocal
Who may be able to join
- Presenting with symptoms of urethritis (dysuria and/or urethral discharge)
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mycoplasma Genitalium Infection
- Being tested
- Comparison of two standard of care regimens
- Keywords
- mycoplasma genitalium, urethritis, NGU, treatment
- Medical subject headings
- Urethritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of two standard of care regimensDrug
Treatment according to results of laboratory detection of resistance markers
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Men treated for mycoplasma according to standard of care Receives: 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 Receives: Drug: Comparison of two standard of care regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with Molecular Clearance
DNA negative for mycoplasma
Measured: 90 days
Secondary outcomes (1)
Positive Participants with Macrolide-Resistant Mycoplasma
DNA positive for macrolide-resistant mycoplasma
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start19 Nov 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: Covid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycoplasma Genitalium InfectionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Van Der Pol, University of Alabama at Birmingham
- Investigators
- Barbara Van Der Pol, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910907
- Sponsor's protocol ID
- IRB-300003178
- Status last verified
- Jun 2023
- First submitted
- 8 Apr 2019
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03910907
- Acronym / sponsor ID
- IRB-300003178
- Conditions
- Mycoplasma Genitalium Infection
- Keywords
- mycoplasma genitalium, urethritis, NGU, treatment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | – | Drug: Comparison of two standard of care regimensMen treated for mycoplasma according to standard of care |
| Standard of care plus | – | Drug: Comparison of two standard of care regimensMen treated for mycoplasma according to standard of care with regimen selected based on laboratory detection of resistance markers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with non-gonoccocal
Key inclusion criteria (1 listed)
- Presenting with symptoms of urethritis (dysuria and/or urethral discharge)
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of two standard of care regimensTreatment according to results of laboratory detection of resistance markers | Drug | Standard of care, Standard of care plus |
Primary outcome
Participants with Molecular Clearance
Time frame: 90 days
DNA negative for mycoplasma
1 secondary outcome
Positive Participants with Macrolide-Resistant Mycoplasma
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Covid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Van Der Pol, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycoplasma Genitalium Infection, run by University of Alabama at Birmingham at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Covid). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with Molecular Clearance (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2023.