Recruiting

Doxycycline

Sponsor:

Jonathan Troy Grennan

Code:

NCT04762134

Conditions

Bacterial Sexually Transmitted Diseases

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxycycline Hyclate

Study Details

Brief summary:

There is a growing epidemic of the bacterial sexually transmitted infections (STIs) syphilis, chlamydia and gonorrhea worldwide; similarly concerning trends have been noted in Canada, where increases of over 160% have been seen in bacterial STIs over the last decade. In Canada, gay, bisexual, and other men who have sex with men (gbMSM) - including those living with HIV - are disproportionately impacted by bacterial STIs5,6These dramatic increases in bacterial STIs, the potential development of serious complications including AMR, and waning effectiveness of the promotion of conventional STI prevention tools (e.g. condoms), signals the need for novel STI prevention strategies and tools to mitigate STI-related complications. A rigorous randomized controlled trial will be conducted to compare STI PrEP vs. STI PEP and definitively assess the efficacy, safety, antimicrobial resistance profiles and costs associated with doxycycline-based STI prevention.

Conditions

Bacterial Sexually Transmitted Diseases

Study ID

NCT04762134

Start date

Jun 2, 2023

Status verified date

Aug, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males, ≥ 18 years of age;
2. Any sexual activity (i.e. oral sex, insertive or receptive anal sex, with or without a condom) with more than one male partner in the preceding 12 months;
3. Intention to remain sexually active with more than one male partner in the next 12 months;
4. At least one prior episode of a previously diagnosed and adequately treated syphilis, gonorrhea or chlamydia infection within 12 months prior to screening.

Exclusion Criteria:

1. Known allergy to doxycycline or tetracyclines;
2. Existing chronic or intermittent tetracycline or doxycycline use (e.g. for chronic osteomyelitis, acne).
3. Use of medications which could lower doxycycline levels, including barbiturates, phenytoin and carbamazepine.
4. Individuals currently using isotretinoin;
5. Any individual capable of becoming pregnant.

Study Design

Enrollment

560 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: STI PrEP arm

doxycycline capsules 100mg orally daily for 12 months. Though the usual treatment dose of doxycycline is 100mg twice daily

experimental: STI PEP arm

doxycycline 200mg orally once within 24-72 hours following each sexual encounter deemed at risk (i.e. condomless anal or oral sex), to a maximum of six pills (i.e. 600 mg total) per week

Interventions

Doxycycline Hyclate

STI PrEP arm: doxycycline capsules 100mg orally daily for 12 months STI PEP arm: doxycycline 200mg orally once within 24-72 hours following each sexual encounter deemed at risk (i.e. condomless anal or oral sex), to a maximum of six pills (i.e. 600 mg total) per week

Primary outcome measure

  • Plasma doxycycyline levels to determine efficacy of doxycycline chemoprophylaxis [ Time Frame: 60 weeks ]

Central Contacts and Locations

Central contacts

Saira Mohammed

6047542171smohammed@bccfe.ca

Troy Grennan

6047075606troy.grennan@bccdc.ca

Locations

Sheldon Chumir Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Grace Kwon

disco@ucalgary.ca

Principal Investigator:

Caley Shukalek, MD

BC Centre for Disease Control

Recruiting

Vancouver, British Columbia, Canada, V5Z4R4

Contacts

Ramin Azmin

6047075617

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Reva Persaud

optionslab@unityhealth.to

Stanley Onyegbule

optionslab@unityhealth.to

Principal Investigator:

Darrell Tan, MD

McGill University Health Centre

Recruiting

Montréal, Quebec, Canada

Contacts

Nathalie Paisible

nathalie.paisible@muhc.mcgill.ca

Turna Hortoglu

turna.hortoglu@muhc.mcgill.ca

Principal Investigator:

Joseph Cox, MD

More Information

Sponsor

Jonathan Troy Grennan

Last update posted

Aug 5, 2024

Last verified

Aug, 2024

Keywords

  • Sexually transmitted infections (STIs)
  • Doxycycline
  • Pre-exposure prophylaxis (PrEP)
  • Post-exposure prophylaxis (PEP)
  • Gay, bisexual, men who have sex with other men (gbMSM)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jonathan Troy Grennan on 2024-08-05.