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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06069141
Collaborator
National Taiwan University Hospital Hsin-Chu Branch (Other), National Taiwan University Hospital, Yun-Lin Branch (Other), Far Eastern Memorial Hospital (Other), Taipei Veterans General Hospital, Taiwan (Other), Taoyuan General Hospital (Other), China Medical University Hospital (Other), National Cheng-Kung University Hospital (Other), Chi Mei Medical Hospital (Other), Chiayi Christian Hospital (Other), Kaohsiung Medical University Chung-Ho Memorial Hospital (Other), Kaohsiung Veterans General Hospital. (Other)
688
Enrollment
2
Arms
38
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Benzathine Penicillin G
  • Drug: Doxycycline Capsule
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
688 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: single-dose BPG plus doxycycline

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

Drug: Benzathine Penicillin G
Benzathine Penicillin G (2.4 MU intramuscularly once)

Drug: Doxycycline Capsule
doxycycline (100 mg orally twice daily for 7 days)
Placebo Comparator: single-dose BPG

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

Drug: Benzathine Penicillin G
Benzathine Penicillin G (2.4 MU intramuscularly once)

Outcome Measures

Primary Outcome Measures

  1. Serologic response [Weeks 24 and week 48]

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

Secondary Outcome Measures

  1. Microbiologic response of syphilis [Week 4]

    T. pallidum PCR Ct value >38

  2. Microbiologic response of bacterial STIs [Week 4]

    negative STI PCR results

  3. Safety of study treatment [Week 4]

  4. Adherence evaluation of tablet intake [Week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Taiwan University Hospital
  • 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.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT06069141
Other Study ID Numbers:
  • 202305061MINA
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
syphilis
rapid plasma reagin
Additional relevant MeSH terms:
Syphilis
Syphilis, Latent
Doxycycline
Penicillins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine

Study Results

No Results Posted as of Oct 5, 2023