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

NCT06069141 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Early Syphilis, Latent, Serological Relapse After Treatment

Interventions

DRUG

Benzathine Penicillin G

Benzathine Penicillin G (2.4 MU intramuscularly once)

DRUG

Doxycycline Capsule

doxycycline (100 mg orally twice daily for 7 days)

Sponsors & Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch

    collaborator OTHER

  • Far Eastern Memorial Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Taoyuan General Hospital

    collaborator OTHER_GOV

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Chi Mei Medical Hospital

    collaborator OTHER

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06069141 on ClinicalTrials.gov