We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04762134
Previous Study | Return to List | Next Study

Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04762134
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jonathan Troy Grennan, British Columbia Centre for Disease Control

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 definitively assess the efficacy, safety, antimicrobial resistance profiles and costs associated with doxycycline-based STI prevention

Condition or disease Intervention/treatment Phase
Bacterial Sexually Transmitted Diseases Drug: Doxycycline Hyclate Phase 2 Phase 3

Detailed Description:
With the rising rates of STIs among gbMSM populations in Canada, there is an urgent need for novel interventions to prevent significant sequelae (e.g. neurosyphilis) and onward transmission of untreated infections. Despite longstanding public health efforts to encourage conventional strategies of STI prevention, gbMSM continue to bear the burden of syphilis which poses synergistic effects in the transmission of HIV. This study will add to this field through providing the first methodologically rigorous, prospective multicentre, open-label randomized controlled trial (RCT) of doxycycline-based STI PrEP (daily 100mg doxycycline) and STI PEP (200mg doxycycline after exposure event) versus standard-of-care for the prevention of bacterial STIs among gbMSM over 15 months (60 weeks) of follow-up with adequate power to address drug efficacy in the prevention of bacterial STIs. Beyond the determination of efficacy, our trial will provide insight to the unique challenges of medication adherence through assessing the acceptability, tolerability and safety of therapy with doxycycline. This study aims to provide health care providers one additional tool to address the burden of STIs in populations with an increased likelihood of infection.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization with a 1:1:1 ratio
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Doxycycline Chemoprophylaxis for the Prevention of Sexually Transmitted Infections in Gay, Bisexual and Other Men Who Have Sex With Men (gbMSM)
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025


Arm Intervention/treatment
Experimental: STI PrEP arm
doxycycline capsules 100mg orally daily for 12 months. Though the usual treatment dose of doxycycline is 100mg twice daily
Drug: 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

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
Drug: 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

No Intervention: Control/Standard of care arm
routine STI screening and care, which for sexually active gbMSM would not include any chemoprophylaxis for STI, as no clinical guidelines currently recommend its use



Primary Outcome Measures :
  1. Plasma doxycycyline levels to determine efficacy of doxycycline chemoprophylaxis [ Time Frame: 60 weeks ]
    To determine the efficacy of doxycycline chemoprophylaxis in preventing incident bacterial STI cases (syphilis, gonorrhea, and/or chlamydia, including LGV)


Secondary Outcome Measures :
  1. Frequency of STIs over time [ Time Frame: 60 weeks ]
    To describe frequency of syphilis, gonorrhea, and chlamydia incident infections among participants over the study period

  2. Proportion of individuals reporting grade 3 or 4 adverse events in each study arm as assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events [ Time Frame: 60 weeks ]
    To determine the tolerability and safety of doxycycline chemoprophylaxis

  3. Proportion of participants who report acceptability, community norms and partner attitudes of STI PrEP and PEP based on responses from questionnaires [ Time Frame: 60 weeks ]
    To determine the acceptability of doxycycline chemoprophylaxis

  4. Change in self-reported sexual activity defined as increases in condomless sexual acts and number of sexual partners based on responses from questionnaires [ Time Frame: 60 weeks ]
    To evaluate the change in sexual behaviour reported by participants over the study period

  5. Proportion of individuals with evidence of tetracycline class resistance in common flora (Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae) at 24 and 48 weeks. [ Time Frame: Over 48 weeks ]
    To evaluate antimicrobial resistance in bacterial STIs and common commensal pathogens over study period

  6. Proportion of cases with resistance to penicillins, tetracyclines or macrolides in syphilis, and tetracycline resistance in gonorrhea and chlamydia isolates taken from the anus, oral cavity or urethra. [ Time Frame: Over 48 weeks ]
    To evaluate antimicrobial resistance in bacterial STIs and common commensal pathogens over study period

  7. Proportion of individuals with adverse event-related study drug discontinuation in each study arm [ Time Frame: Over 60 weeks ]
    To determine the tolerability and safety of doxycycline chemoprophylaxis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   gay, bisexual, and other men who have sex with men
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04762134


Contacts
Layout table for location contacts
Contact: Saira Mohammed 6047542171 smohammed@bccfe.ca
Contact: Troy Grennan 6047075606 troy.grennan@bccdc.ca

Sponsors and Collaborators
Jonathan Troy Grennan
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Troy Grennan, MD University of British Columbia
Layout table for additonal information
Responsible Party: Jonathan Troy Grennan, Principal Investigator, British Columbia Centre for Disease Control
ClinicalTrials.gov Identifier: NCT04762134    
Other Study ID Numbers: BritishCCDC3
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Our results will be targeted to four main groups of stakeholders: clinicians, public health, researchers, and community.The Community-Based Research Centre for Gay Men's Health, the Canadian AIDS Treatment Information Exchange (CATIE), and the AIDS Committee of Toronto will help facilitate KTE locally and nationally. We will disseminate our findings to a large, international audience of clinicians and public-health professionals by publishing in high-impact peer-reviewed journals.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Troy Grennan, British Columbia Centre for Disease Control:
Sexually transmitted infections (STIs)
Doxycycline
Pre-exposure prophylaxis (PrEP)
Post-exposure prophylaxis (PEP)
Gay, bisexual, men who have sex with other men (gbMSM)
Additional relevant MeSH terms:
Layout table for MeSH terms
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Communicable Diseases
Infections
Disease Attributes
Pathologic Processes
Bacterial Infections
Bacterial Infections and Mycoses
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents