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A randomized, comparative pilot study of azithromycin versus benzathine penicillin G for treatment of early syphilis.
Abstract
BACKGROUND: Penicillin is the only medication currently recommended for treatment of early syphilis in non-penicillin-allergic patients. Preliminary data suggest that azithromycin may be effective for syphilis therapy. STUDY DESIGN: This was a randomized, comparative pilot study of intramuscular injections of benzathine penicillin G and two oral azithromycin regimens for treatment of syphilis. METHODS: We randomly assigned patients with early syphilis to treatment with either intramuscular injections of 2.4 million units of benzathine penicillin G or azithromycin administered orally, either as a single 2.0-g dose or as two 2.0-g doses given 1 week apart. Serological response to therapy was evaluated at 3, 6, 9, and 12 months following therapy. Participants whose rapid plasma reagin (RPR) test became nonreactive or whose RPR titer decreased > or =2 dilutions were classified as responding to therapy. When serological tests did not show a response to therapy, the treatment was classified as a failure if RPR titers increased > or =2 dilutions. Nonresponders were those whose serologic titers remained within +/-1 dilution of the initial RPR titer. RESULTS: Cumulative response rates were as follows: benzathine penicillin G, 86% (12 of 14); azithromycin, 2.0-g single dose, 94% (16 of 17); and azithromycin, two 2.0-g doses given 1 week apart, 83% (24 of 29). Therapy failed for one patient treated with benzathine penicillin and one patient treated with the two-dose azithromycin regimen, whereas in six patients the clinical manifestations of infection resolved but there was no serological response. CONCLUSION: Oral therapy with 2.0 g of azithromycin as a single dose or as two doses 1 week apart is a promising alternative to therapy with benzathine penicillin G for syphilis and should be studied further.
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“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 [602]
In the citing paper
“Azithromycin as a single 2-g oral dose has been effective for treating primary and secondary syphilis among certain populations (602,604,605).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [602]
In the citing paper
“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 [602]
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Sexually Transmitted Infections Treatment Guidelines, 2021
Workowski, K. A., Bachmann, L. H., Chan, P. A., Johnston, C. M., Muzny, C. A., Park, I., Reno, H., Zenilman, J. M., & Bolan, G. A. (2021) · MMWR. Recommendations and Reports · doi:10.15585/mmwr.rr7004a1 · Cited by 3,018
Sexually transmitted diseases treatment guidelines
Burstein, G. R., & Workowski, K. (2003) · Current Opinion in Pediatrics · doi:10.1097/00008480-200308000-00006 · Cited by 2,077
Sexually Transmitted Diseases Treatment Guidelines, 2010
Workowski, K., & BOLAN, G. A. (2011) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2011.04.006 · Cited by 2,074
Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines
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Metadata
- Authors
- HOOK, E. W., MARTIN, D. H., STEPHENS, J., SMITH, B. S., & SMITH, K.
- Affiliations
- University of Alabama at Birmingham (US)
- Louisiana State University Health Sciences Center New Orleans (US)
- Jefferson County Department of Health (US)
- Corresponding author
- HOOK, EDWARD W.
- SMITH, KIM
- Venue
- Sexually Transmitted Diseases
- Published
- 2002-08
- Volume
- 29
- Issue
- 8
- Pages
- 486-490
- ISSN
- 0148-5717 (ISSN-L)
- OpenAlex
- W2018162609
- Cited by
- 135
- References
- 15
- Citations by year
- 2026: 1 · 2024: 1 · 2023: 1 · 2021: 3 · 2020: 4 · 2019: 2 · 2018: 1 · 2017: 3 · 2016: 8 · 2015: 6 · 2014: 3 · 2013: 9 · 2012: 9
- FWCI
- 6.49
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Sexually Transmitted Diseases (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Syphilis Diagnosis and Treatment
- Health Sciences › Medicine › Pharmacology (medical) › Historical Medical Research and Treatments
- Life Sciences › Immunology and Microbiology › Parasitology › Vector-borne infectious diseases
- Keywords
- early syphilis, azithromycin, benzathine penicillin G, oral antibiotic therapy, intramuscular penicillin, serological response, RPR, treatment failure
- MeSH terms
- Administration, Oral, Adolescent, Adult, Anti-Bacterial Agents, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Injections, Intramuscular, Male, Middle Aged, Penicillin G Benzathine, Penicillins, Pilot Projects, Reagins, Syphilis, Treponema pallidum, Azithromycin
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