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Self-taken Penile Meatal Swabs for Chlamydia, Gonorrhoea and Mycoplasma Genitalium Detection (Me-swab)

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ClinicalTrials.gov Identifier: NCT04244994
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Brief Summary:

Objectives:

To compare self-taken penile meatal swabs versus first-catch urine samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium from the penile urethra using nucleic acid amplification tests.

To assess the acceptability of self-taken penile meatal swabs compared with first-catch urine samples.

To assess the prevalence of Mycoplasma genitalium in those with urethritis.

To assess the prevalence of Mycoplasma genitalium antimicrobial resistance.

To evaluate the utility of using Mycoplasma genitalium resistance-guided therapy.

To compare the cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium.

Methods:

Men and transwomen presenting for a sexual health screen will perform a self-taken penile meatal swab followed by a first-catch urine (FCU) sample. Both will be analysed using the Aptima Combo 2 test (Hologic, San Diego, California [CA], USA) for chlamydia and gonorrhoea. In those with urethritis they will also be analysed using Aptima MGen test for Mycoplasma genitalium. Details of demographics, past history, sexual history, clinical symptoms and signs will be collected. The acceptability of each sample will be assessed using a patient questionnaire. The samples of those infected with Mycoplasma genitalium will be tested for Mycoplasma genitalium macrolide and fluoroquinolone resistance mutations by in-house polymerase chain reaction (PCR) using Sanger sequencing to characterise mutants in the 23s gene for macrolide resistance and DNA gyrase subunit A (gyrA) and DNA topoisomerase IV subunit C (parC) genes for fluoroquinolone resistance. The result of this will be used to guide the therapy prescribed to treat the infection.

Primary outcome:

Sensitivity, specificity, positive and negative predictive values of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium in the penile urethra.

Secondary outcomes:

Acceptability of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium.

Prevalence of Mycoplasma genitalium in those with urethritis.

Prevalence of Mycoplasma genitalium antimicrobial resistance.

Utility of using Mycoplasma genitalium resistance-guided therapy.

Cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium.


Condition or disease Intervention/treatment Phase
Sexually Transmitted Diseases, Bacterial Device: Aptima-Combo2 and Aptima Mgen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Comparison of self-taken penile meatal swabs (intervention) versus first-catch urine (control) for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium in all participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Self-taken Penile Meatal Swabs Versus First-catch Urine for the Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Neisseria

Arm Intervention/treatment
Intervention and Control
Self-taken penile meatal swabs versus first-catch urine for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium using Aptima-Combo2 and Aptima Mgen
Device: Aptima-Combo2 and Aptima Mgen
Self-taken penile meatal swabs versus first-catch urine samples for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium using Aptima-Combo2 and Aptima Mgen




Primary Outcome Measures :
  1. Sensitivities, specificities, positive and negative predictive values [ Time Frame: At time of enrollment ]
    Sensitivity, specificity, positive and negative predictive values of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium in the penile urethra.


Secondary Outcome Measures :
  1. Participant reported acceptability of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium. [ Time Frame: At time of enrollment ]
    Participant-reported acceptability of self-taken penile meatal swabs compared with FCU samples. The participants will complete questions on how easy/difficult, and comfortable/uncomfortable, they found taking the penile meatal swab compared to collecting the FCU and their overall sample preference of sample.

  2. Prevalence of Mycoplasma genitalium in those with urethritis. [ Time Frame: At time of enrollment ]
    Prevalence of Mycoplasma genitalium in those with urethritis.

  3. Prevalence of Mycoplasma genitalium antimicrobial resistance. [ Time Frame: At time of enrollment ]
    Prevalence of Mycoplasma genitalium antimicrobial resistance.

  4. Utility of using Mycoplasma genitalium resistance-guided therapy to prevent inappropriate antibiotic use. [ Time Frame: 6 months after enrollment ]
    The utility of using AMR-guided therapy will be measured by the numbers of participants that would have been given inappropriate antibiotics if the NGU guideline had been followed by giving doxycycline, then extended azithromycin, then moxifloxacin compared to resistance-guided therapy.

  5. Cost comparison [ Time Frame: At time of enrollment ]
    Cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium.



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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
Gender Eligibility Description:   Males and trans-women with male genitalia
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and transwomen who have male genitalia
  • Aged 18 and over
  • Ever sexually active
  • Presenting to Leeds Sexual Health wishing to be tested for chlamydia, gonorrhoea and M. genitalium (if symptoms of urethritis are present)
  • Give verbal consent

Exclusion Criteria:

  • Never sexually active
  • Non-male genitalia
  • Unwilling to give verbal consent
  • Unwilling to perform a self-taken penile meatal swab and unwilling/unable to perform a first-catch urine sample
  • Having taken antibiotics (other than metronidazole) in the past 14 days

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): NCT04244994


Contacts
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Contact: Janet Wilson, MB ChB 00 44 0113 3920323 janet-d.wilson@nhs.net
Contact: Michelle Loftus-Keeling 00 44 113 3920323 michelle.loftus-keeling@nhs.net

Locations
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United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Contact: Janet Wilson, MB ChB    00 44 113 3920323    janet-d.wilson@nhs.net   
Contact: Michelle Loftus-Keeling    00 44 113 3920323    michelle.loftus-keeling@nhs.net   
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
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Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04244994    
Other Study ID Numbers: GU/125925
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The Leeds Teaching Hospitals NHS Trust:
Chlamydia trachomatis
Neisseria gonorrhoeae
Mycoplasma genitalium
Additional relevant MeSH terms:
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Chlamydia Infections
Sexually Transmitted Diseases
Gonorrhea
Mycoplasma Infections
Sexually Transmitted Diseases, Bacterial
Pleuropneumonia
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Virus Diseases
Neisseriaceae Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections