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Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline

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ClinicalTrials.gov Identifier: NCT05980871
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 10, 2023
Estimated Primary Completion Date : March 15, 2025
Estimated Study Completion Date : March 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syphilis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Rate of serologic response at month 6 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 4 ]
    Microbiologic response of bacterial STIs is defined as negative PCR results

  3. Rate of serologic response at months 3 and 12 [ Time Frame: 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
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05980871


Contacts
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Contact: Kuan-Yin Lin +886975607715 kuanyin0828@gmail.com

Locations
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Taiwan
Kuan-Yin Lin Recruiting
Taipei, Taiwan, 110
Contact: Kuan-Yin Lin    +886975607715    maregold@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kuan-Yin Lin National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT05980871    
Other Study ID Numbers: 202206138MIND
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Syphilis
Treponemal Infections
Spirochaetales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Communicable Diseases
Genital Diseases
Urogenital Diseases
Doxycycline
 Ceftriaxone
Penicillins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Third Generation Cephalosporins
Beta Lactam Antibiotics