A multicenter study evaluating ceftriaxone and benzathine penicillin G as treatment agents for early syphilis in Jiangsu, China.
Open accessAbstract
BACKGROUND: The aim of this study was to assess the efficacy of ceftriaxone and benzathine penicillin G (BPG) in nonpregnant, immunocompetent adults with early syphilis because there is a lack of clinical evidence supporting ceftriaxone as an alternative treatment for early syphilis without an human immunodeficiency virus coinfection. METHODS: A randomized, open-label controlled study evaluating the efficacy of ceftriaxone and BPG was conducted in 4 hospitals in Jiangsu Province. Treatment comprised either ceftriaxone (1.0 g, given intravenously, once daily for 10 days) or BPG (2.4 million units, given intramuscularly, once weekly for 2 weeks). A serological response was defined as a ≥4-fold decline in the rapid plasma reagin (RPR) titer. RESULTS: In all, 301 patients with early syphilis were enrolled in this study; 230 subjects completed the follow-ups. The serological response at 6 months of follow up was observed in 90.2% in ceftriaxone group and 78.0% in BPG group (P = .01). There was no significant difference between treatment groups in patients with primary or early latent syphilis, but among patients with secondary syphilis the difference was highly significant (95.8% vs 76.2%; P < .01). Moreover, patients exhibiting a Jarisch-Herxheimer reaction after treatment might have a shorter period before a serological response (P = .03). CONCLUSIONS: In this study, ceftriaxone regimen was noninferior to the BPG regimen in nonpregnant, immunocompetent patients with early syphilis. CLINICAL TRIALS REGISTRATION: ChiCTR-TQR-13003624.
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Ceftriaxone (1 g daily either IM or IV for 10 days) is effective for treating primary and secondary syphilis.
“Limited clinical studies, along with biologic and pharmacologic evidence, indicate that ceftriaxone (1 g daily either IM or IV for 10 days) is effective for treating primary and secondary syphilis”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [603]
The Abstract and Discussion (page numbers not supplied) support ceftriaxone’s effectiveness for primary and secondary syphilis with 1 g daily for 10 days. The study administered it intravenously; our copy does not establish that the intramuscular route is effective with this regimen. (LLM, conf=0.90)
Experimental — accuracy not yet measuredCeftriaxone 1-2 g daily either IM or IV for 10-14 days can be used as an alternative treatment for persons with neurosyphilis.
“Limited data indicate that ceftriaxone 1–2 g daily either IM or IV for 10–14 days can be used as an alternative treatment for persons with neurosyphilis (603,616,617).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [603]
The Discussion (page not provided) reports that ceftriaxone may be an option for CNS syphilis and has reportedly been effective for neurosyphilis. It does not give the claimed neurosyphilis regimen of 1–2 g daily by IM or IV injection for 10–14 days; the 1 g IV daily for 10 days described in the paper was studied for early syphilis. (LLM, conf=0.87)
Experimental — accuracy not yet measuredSeveral different ceftriaxone regimens have been shown to be effective for the treatment of early syphilis.
“Several different ceftriaxone regimens have been shown to be effective for the treatment of early syphilis.104–113”
From BASHH UK guidelines for the management of syphilis 2024 (2024) · cites this paper as [113]
The Abstract reports that one ceftriaxone regimen—1.0 g intravenously daily for 10 days—was noninferior to benzathine penicillin G for early syphilis in nonpregnant, immunocompetent patients. The Discussion also reports favorable results from a meta-analysis, but our copy does not establish that several different ceftriaxone regimens were effective. Page numbers were not provided for these passages. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe optimal dose and duration of ceftriaxone therapy for primary and secondary syphilis have not been defined.
“however, the optimal dose and duration of ceftriaxone therapy have not been defined (602,603).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [603]
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- Authors
- Cao, Y., Su, X., Wang, Q., Xue, H., Zhu, X., Zhang, C., Jiang, J., Qi, S., Gong, X., Zhu, X., Pan, M., Ren, H., Hu, W., Wei, Z., Tian, M., & Liu, W.
- Affiliations
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Northern Jiangsu People's Hospital (CN)
- The First People’s Hospital of Lianyungang (CN)
- Xuzhou Medical College (CN)
- Corresponding author
- Su, Xiaohong
- ORCID
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-07-17
- Volume
- 65
- Issue
- 10
- Pages
- 1683-1688
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- OpenAlex
- W2735671091
- Cited by
- 51
- References
- 30
- Citations by year
- 2026: 8 · 2025: 5 · 2024: 9 · 2023: 8 · 2022: 7 · 2021: 6 · 2020: 5 · 2019: 1 · 2018: 2
- FWCI
- 1.62
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Government of Jiangsu Province (BL2012003)
- Topics
- Health Sciences › Medicine › Physiology › Syphilis Diagnosis and Treatment
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Historical Medical Research and Treatments
- Life Sciences › Immunology and Microbiology › Parasitology › Vector-borne infectious diseases
- Keywords
- early syphilis, ceftriaxone, benzathine penicillin G, antibiotic efficacy, serological response, RPR, Jarisch-Herxheimer reaction, secondary syphilis, primary syphilis, latent syphilis, non-inferiority
- MeSH terms
- Adolescent, Adult, Aged, Anti-Bacterial Agents, Ceftriaxone, China, Female, Follow-Up Studies, Humans, Male, Middle Aged, Penicillin G Benzathine, Syphilis, Syphilis Serodiagnosis, Young Adult
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