Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05980871
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.2
• Patients Per Site Per Month: 12.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Early Syphilis	Drug: Doxycycline; Drug: Ceftriaxone; Drug: benzathine penicillin G	Phase 4

Detailed 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)

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment Responses of Early Syphilis to Single-dose Ceftriaxone Plus Doxycycline Versus Single-dose Benzathine Penicillin G Plus Doxycycline in PLWH
• Actual Study Start Date: Mar 10, 2023
• Anticipated Primary Completion Date: Mar 15, 2025
• Anticipated Study Completion Date: Mar 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: single-dose ceftriaxone plus doxycycline single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)	Drug: Doxycycline; doxycycline (100 mg orally twice daily for 7 days); Drug: Ceftriaxone; Ceftriaxone (1g intramuscularly once)
Active Comparator: single-dose BPG plus doxycycline single-dose BPG (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)	Drug: Doxycycline; doxycycline (100 mg orally twice daily for 7 days); Drug: benzathine penicillin G; benzathine penicillin G (2.4 MU intramuscularly once)

Outcome Measures

Primary Outcome Measures

1. Rate of serologic response at month 6 [Month 6]

   Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive

Secondary Outcome Measures

1. Rate of microbiologic response of syphilis at week 4 [Week 4]

   Microbiologic response of syphilis is defined as T. pallidum PCR Ct value >38

2. Rate of microbiologic response of bacterial STIs at week 4 [Week 4]

   Microbiologic response of bacterial STIs is defined as negative PCR results

3. Rate of serologic response at months 3 and 12 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuan-Yin Lin	Taipei		Taiwan	110

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Kuan-Yin Lin, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05980871
• Other Study ID Numbers: 202206138MIND
• First Posted: Aug 8, 2023
• Last Update Posted: Aug 8, 2023
• Last Verified: Mar 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
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Syphilis; Doxycycline; Ceftriaxone; Penicillins; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine

Study Results

No Results Posted as of Aug 8, 2023