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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05980871
Other study ID # 202206138MIND
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 10, 2023
Est. completion date March 15, 2025

Study information

Verified date March 2023
Source National Taiwan University Hospital
Contact Kuan-Yin Lin
Phone +886975607715
Email kuanyin0828@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In a prospective study investigating the prevalence of STIs among at-risk PLWH, the prevalence of Chlamydia trachomatis and N. gonorrhoeae was 24.7% and 12.1%, respectively. Surprisingly, the study found high rates of C. trachomatis and/or N. gonorrhoeae co-infections in PLWH with recent hepatitis C virus (HCV) infection (50%), HBsAg positivity (44%), and early syphilis (36%). Considering the high rate of sexually transmitted co-infections, combination therapy of single-dose ceftriaxone plus 7-day doxycycline for early syphilis may provide convenience and benefit to treatment of N. gonorrhoeae and C. trachomatis co-infections at a single clinic encounter. In the present study, this study aim to compare the efficacy of ceftriaxone plus doxycycline versus BPG plus doxycycline as the treatment for early syphilis among PLWH.


Description:

Enrolled criteria: 1. PLWH aged 20 years or more 2. PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum particle agglutination (TPPA) assay. 3. PLWH has provided informed consent *A participant with repeated syphilis can be repeated enrolled after signing an informed consent if the previous episode of early syphilis was successfully treated with achieving at least a 4-fold decrease in RPR titers and 48-week follow-up is completed. Exclusion criteria: 1. PLWH with RPR titers of less than 4 2. Exposure to antibiotics with activity against T. pallidum, such as penicillins, third-generation cephems, doxycycline, or macrolides, within the preceding 4 weeks 3. A known or suspected infection other than syphilis requiring additional treatment with an antimicrobial active against T. pallidum 4. A history of intolerance to penicillin, ceftriaxone, or doxycycline 5. Pregnancy Primary outcome: Serologic response at month 6 (defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive) Secondary outcomes: 1. Microbiologic response of syphilis (defined as T. pallidum PCR Ct value >38) at week 4 2. Microbiologic response of bacterial STIs (defined as negative PCR results) at week 4 3. Serologic response at months 3 and 12 4. Safety of study treatment recorded by using a diary (all adverse events will be coded and graded according to Common Terminology Criteria for Adverse Events [CTCAE] v4.0.) 5. Adherence evaluation (the noting of tablet intake in the diary for the 7 days of the treatment period)


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date March 15, 2025
Est. primary completion date March 15, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - PLWH aged 20 years or more - PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum particle agglutination (TPPA) assay. - PLWH has provided informed consent Exclusion Criteria: - PLWH with RPR titers of less than 4 - Exposure to antibiotics with activity against T. pallidum, such as penicillins, third- generation cephems, doxycycline, or macrolides, within the preceding 4 weeks - A known or suspected infection other than syphilis requiring additional treatment with an antimicrobial active against T. pallidum - A history of intolerance to penicillin, ceftriaxone, or doxycycline - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Doxycycline
doxycycline (100 mg orally twice daily for 7 days)
Ceftriaxone
Ceftriaxone (1g intramuscularly once)
benzathine penicillin G
benzathine penicillin G (2.4 MU intramuscularly once)

Locations

Country Name City State
Taiwan Kuan-Yin Lin Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of serologic response at month 6 Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive Month 6
Secondary Rate of microbiologic response of syphilis at week 4 Microbiologic response of syphilis is defined as T. pallidum PCR Ct value >38 Week 4
Secondary Rate of microbiologic response of bacterial STIs at week 4 Microbiologic response of bacterial STIs is defined as negative PCR results Week 4
Secondary Rate of serologic response at months 3 and 12 Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive Months 3 and 12
See also
  Status Clinical Trial Phase
Completed NCT03660488 - Cefixime for Alternative Syphilis Treatment Phase 2
Completed NCT01944358 - Comparisons of Serologic Response of Early Syphilis N/A