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A Randomized Controlled Trial of Ceftriaxone Combined with IL-2 in the Treatment of Syphilis Patients with Serum Fixation.

A Randomized Controlled Trial of Ceftriaxone Combined with IL-2 in the Treatment of Syphilis Patients with Serum Fixation.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080596
Enrollment
Unknown
Registered
2024-02-02
Start date
2023-08-25
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis with Serum Fixation

Interventions

test group:Ceftriaxone 2 g / day for 14 days, IL-2 500000 U / time (dissolved in 2ml injection water) 3 times a week for 6 weeks
control group:Ceftriaxone 2 g / day for 14 days, Placebo (2ml injection water) 3 times a week for 6 weeks

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) the patients who are 18-60 years old, regardless of gender; (2) the patients who had received regular antisyphilis treatment; (3) the rapid plasma Reagin ring card test (RPR/TRUST) did not turn negative for stage I syphilis with complete follow-up data for more than one year, or for stage II syphilis with complete follow-up data, the rapid plasma Reagin ring card test (RPR/TRUST) did not turn negative for more than 2 years. Or the patients with advanced syphilis were regularly treated with syphilis for more than 3 years, and the rapid plasma Reagin ring card test (RPR/TRUST) did not turn negative. (4) the patients who were willing to cooperate with this project signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) patients with syphilis reinfection; (2) patients with recurrent syphilis; (3) patients less than 18 years old or more than 60 years old; (4) patients with severe heart and liver (heart function is divided into 4 grades, belonging to grade 3-4; ALT > normal value 1.5 times), renal insufficiency (Cr > 133umol/L) or hematopoietic dysfunction, bleeding tendency and hemorrhagic diseases. And patients with malignant tumors, mental illness, rheumatoid disease, systemic lupus erythematosus and other medical diseases; (5) those who have been treated with ceftriaxone sodium because of serum fixation in the past; (6) those who have used immunosuppressants such as corticosteroids for various reasons within the past month; (7) those who are allergic to benzylpenicillin or / and ceftriaxone; (8) pregnant or lactating women; (9) immunocompromised patients. (10) drug addicts; (11) those who are participating in other clinical trials; (12) those who are not easy for long-term follow-up or poor compliance.

Design outcomes

Primary

MeasureTime frame
Serological examination of syphilis(RPR/TRUST);

Secondary

MeasureTime frame
Comprehensive curative effect evaluation;

Countries

China

Contacts

Public ContactZhou Ying

Affiliated Hospital of Guangdong Medical University

zhouy10000@126.com+86 759 236 2539

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026