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Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline

Primary Purpose

Early Syphilis, Latent, Serological Relapse After Treatment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Benzathine Penicillin G
Doxycycline Capsule
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Syphilis, Latent, Serological Relapse After Treatment focused on measuring syphilis, rapid plasma reagin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: People living with HIV (PLWH) aged ≥18 years with early syphilis Confirmed by a positive RPR titer with a reactive TPPA assay Exclusion Criteria: PWH with RPR titers of <4 Exposure to antibiotics with activity against T. pallidum within the preceding 4 weeks (penicillin, 3rd cephalosporin, doxycycline, macrolides) A known or suspected infection requiring additional treatment with an antimicrobial active against T. pallidum (penicillin, 3rd cephalosporin, doxycycline, macrolides) Testing positive for C. trachomatis and M. genitalium, for which doxycycline or macrolide was administered A history of intolerance to penicillin or doxycycline PLWH have already participated in this study Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    single-dose BPG plus doxycycline

    single-dose BPG

    Arm Description

    single-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)

    single-dose benzathine penicillin G (2.4 MU intramuscularly once)

    Outcomes

    Primary Outcome Measures

    Serologic response
    Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive

    Secondary Outcome Measures

    Microbiologic response of syphilis
    T. pallidum PCR Ct value >38
    Microbiologic response of bacterial STIs
    negative STI PCR results
    Safety of study treatment
    Adherence evaluation of tablet intake

    Full Information

    First Posted
    October 1, 2023
    Last Updated
    October 1, 2023
    Sponsor
    National Taiwan University Hospital
    Collaborators
    National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital, Yun-Lin Branch, Far Eastern Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Taoyuan General Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Chiayi Christian Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06069141
    Brief Title
    Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
    Official Title
    Comparisons of Treatment Responses of Early Syphilis to 2.4 Milliunits (MU) Single-dose Benzathine Penicillin G With or Without Doxycycline in People Living With HIV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital, Yun-Lin Branch, Far Eastern Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Taoyuan General Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Chiayi Christian Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomized controlled superiority study will be conducted during 2023-2025. The eligible participants are adult people living with HIV (PLWH) who are newly diagnosed with early syphilis. Participants will be randomized in a 1:1 ratio to receive single-dose benzathine penicillin G (BPG) (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) or single-dose BPG. The primary outcome is serologic response, defined as a decline of rapid plasma reagin (RPR) titer by 4-fold or greater, at week 24 and week 48; and the secondary outcomes include microbiologic response of syphilis and bacterial sexually transmitted infections (STIs) assessed by nucleic-acid amplification test (NAAT) at week 4.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Early Syphilis, Latent, Serological Relapse After Treatment
    Keywords
    syphilis, rapid plasma reagin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    688 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single-dose BPG plus doxycycline
    Arm Type
    Active Comparator
    Arm Description
    single-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
    Arm Title
    single-dose BPG
    Arm Type
    Placebo Comparator
    Arm Description
    single-dose benzathine penicillin G (2.4 MU intramuscularly once)
    Intervention Type
    Drug
    Intervention Name(s)
    Benzathine Penicillin G
    Intervention Description
    Benzathine Penicillin G (2.4 MU intramuscularly once)
    Intervention Type
    Drug
    Intervention Name(s)
    Doxycycline Capsule
    Intervention Description
    doxycycline (100 mg orally twice daily for 7 days)
    Primary Outcome Measure Information:
    Title
    Serologic response
    Description
    Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
    Time Frame
    Weeks 24 and week 48
    Secondary Outcome Measure Information:
    Title
    Microbiologic response of syphilis
    Description
    T. pallidum PCR Ct value >38
    Time Frame
    Week 4
    Title
    Microbiologic response of bacterial STIs
    Description
    negative STI PCR results
    Time Frame
    Week 4
    Title
    Safety of study treatment
    Time Frame
    Week 4
    Title
    Adherence evaluation of tablet intake
    Time Frame
    Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: People living with HIV (PLWH) aged ≥18 years with early syphilis Confirmed by a positive RPR titer with a reactive TPPA assay Exclusion Criteria: PWH with RPR titers of <4 Exposure to antibiotics with activity against T. pallidum within the preceding 4 weeks (penicillin, 3rd cephalosporin, doxycycline, macrolides) A known or suspected infection requiring additional treatment with an antimicrobial active against T. pallidum (penicillin, 3rd cephalosporin, doxycycline, macrolides) Testing positive for C. trachomatis and M. genitalium, for which doxycycline or macrolide was administered A history of intolerance to penicillin or doxycycline PLWH have already participated in this study Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kuan-Yin Lin, MD
    Phone
    +886975607715
    Email
    kuanyin0828@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline

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