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Self-taken Penile Meatal Swabs for Chlamydia, Gonorrhoea and Mycoplasma Genitalium Detection

NCT04244994 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2020-01-28

No results posted yet for this study

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.

Conditions

  • Sexually Transmitted Diseases, Bacterial

Interventions

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

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-08-31
Completion
2022-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04244994 on ClinicalTrials.gov