Doxy Decay: The impact of doxycycline on the organism load and viability of urethral Mycoplasma genitalium and Chlamydia trachomatis

Not Applicable

• Conditions: rethral Mycoplasma genitalium; Urethral Chlamydia trachomatis; Nongonococcal urethritis; Urethral Mycoplasma genitalium; Infection - Sexually transmitted infections

• Registration Number: ACTRN12622001340729
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-18
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 214

Inclusion Criteria

Individuals attending Melbourne Sexual Health Centre (MSHC) will be eligible if they fulfil all the following criteria:
•Are prescribed doxycycline 100mg PO twice daily for 7 days for one of the indications below:
-men attending MSHC with NGU who receive presumptive doxycycline treatment, or
-men attending MSHC for doxycycline treatment (100mg PO twice daily for 7 days) for known or presumed/likely M. genitalium or C. trachomatis urethral infection, or
-men attending MSHC for a urethral M. genitalium test of cure with urethral symptoms and receive presumptive doxycycline treatment, or
-men attending MSHC as a sexual contact of M. genitalium or C. trachomatis with urethral symptoms in whom doxycycline is presumptively prescribed
•Are aged 18 years and older
•Are willing to participate in research
•Can understand and comply with study procedures

Exclusion Criteria

Individuals will be ineligible if they fulfil any of the following criteria:
•Are currently taking or have been prescribed any antibiotics in addition to doxycycline on the day of enrolment.
•Are not fluent in English
•Are unwilling or unable to comply with study procedures

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacterial load of urethral M. genitalium over 7 days of doxycycline as measured by digital PCR using urine samples[Pre doxycycline dose (day 0), day 1, day 2, day 3, day 4, day 5, day 6 and day 7];Bacterial load of urethral C. trachomatis over 7 days of doxycycline as measured by digital PCR using urine samples[Pre doxycycline dose (day 0), day 1, day 2, day 3, day 4, day 5, day 6 and day 7]

Secondary Outcome Measures

Name	Time	Method
Bacterial viability of urethral M. genitalium over 7 days of doxycycline as measured by the InSignia™ viability assay using urine samples[Pre doxycycline dose (day 0), day 1, day 2, day 3, day 4, day 5, day 6 and day 7];Change in male urethral microbiome composition (using urine samples) over 7 days of doxycycline as measured by 16S rRNA gene sequencing and/or shotgun metagenomic sequencing[Pre doxycycline dose (day 0), day 1, day 2, day 3, day 4, day 5, day 6 and day 7];Change in urethral microbiome composition (using urine samples) following 7 days of doxycycline among men with idiopathic urethritis as measured by 16S rRNA gene sequencing and/or shotgun metagenomic sequencing[Pre doxycycline dose (day 0), day 1, day 2, day 3, day 4, day 5, day 6 and day 7];Bacterial viability of urethral C. trachomatis over 7 days of doxycycline as measured by the InSignia™ viability assay using urine samples[Pre doxycycline dose (day 0), day 1, day 2, day 3, day 4, day 5, day 6 and day 7]