Oral Doxycycline for the Prevention of Syphilis in Men Who Have Sex With Men
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|ClinicalTrials.gov Identifier: NCT02864550|
Recruitment Status : Not yet recruiting
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Syphilis Sexually Transmitted Infections||Drug: Doxycycline Other: Placebo||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-controlled Trial of Oral Doxycycline for the Prevention of Syphilis in Men Who Have Sex With Men (MSM)|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Doxycycline arm
Participants in this intervention group will receive doxycycline 100mg orally daily, which is available as a 100mg capsule. This single daily dose was chosen to maximize adherence, given the common use of once-daily Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis (PrEP), as well as its efficacy as once-daily prophylaxis against malaria and its utility as dosing as infrequent as once weekly for another spirochete infection, leptospirosis.
Placebo Comparator: Placebo arm
Participants in this control group will receive a placebo capsule identical in appearance, taste, and size to the capsule provided to the intervention group.
- Number of new (incident) syphilis cases [ Time Frame: Participants will be followed for 15 months ]Given that all participants will have had syphilis infection in the past, and thus their serology will reflect this, a new infection will be defined as a two titre (or four-fold) increase in rapid plasma reagin (RPR) (e.g. 1:2 to 1:8).
- Frequency of adverse events and discontinuations [ Time Frame: Participants will be followed for 15 months ]This will be captured via self-report at each study visit.
- Number of new (incident) cases of any bacterial sexually transmitted infection (i.e. syphilis, gonorrhoea, or chlamydia) [ Time Frame: Participants will be followed for 15 months ]
- Number of doses of study medication taken per week [ Time Frame: Participants will be followed for 15 months ]Measured by (1) self-report; (2) pill counts at each study visit. Additionally, these outcomes will be corroborated with doxycycline serum drug levels.
- Increase in minimum inhibitory concentration (MIC) of either Staphylococcus aureus or Streptococcus pneumoniae to tetracyclines. [ Time Frame: Participants will be followed for 15 months ]
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): NCT02864550
|Contact: Troy Grennan, MD||604-707-5606||Troy.Grennan@bccdc.ca|
|Canada, British Columbia|
|British Columbia Centre for Disease Control||Not yet recruiting|
|Vancouver, British Columbia, Canada, V5Z 4R4|
|Contact: Troy Grennan, MD 604-707-5606 Troy.Grennan@bccdc.ca|
|Principal Investigator:||Troy Grennan, MD||BC Centre for Disease Control|