A phase III equivalence trial of azithromycin versus benzathine penicillin for treatment of early syphilis.
Abstract
BACKGROUND: Syphilis remains an important source of morbidity worldwide. Long-acting penicillin is the only therapy currently recommended for syphilis in much of the world. Because of hesitation to use penicillin for fear of anaphylaxis, there is a need for an effective, well-tolerated alternative to penicillin for syphilis therapy. METHODS: This multicenter, randomized clinical trial was conducted in clinics for the treatment of persons with sexually transmitted diseases. We compared serological cure rates for human immunodeficiency virus (HIV)-negative persons with early syphilis treated with azithromycin at a dosage of 2.0 g administered orally as a single dose with cure rates for those treated with benzathine penicillin G at a dosage of 2.4 million units administered intramuscularly. RESULTS: A total of 517 participants were enrolled in the trial. In the intention-to-treat analysis, after 6 months of follow-up, serological cure was observed in 180 (77.6%) of 232 azithromycin recipients and 186 (78.5%) of 237 penicillin recipients (1-sided lower bound 95% confidence interval, 7.2%). Nonserious adverse events were more common among azithromycin recipients than they were among penicillin recipients (61.5% vs 46.3%), and such adverse events were accounted for, in large part, by self-limited gastrointestinal complaints. CONCLUSIONS: In this trial, the efficacy of azithromycin at a dosage of 2.0 g administered orally was equivalent to that of benzathine penicillin G for the treatment of early syphilis in persons without HIV infection.
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Azithromycin has shown good treponemicidal activity in animal studies and several controlled studies.
“Azithromycin has shown good treponemicidal activity in animal studies and several controlled studies.100,101”
From BASHH UK guidelines for the management of syphilis 2024 (2024) · cites this paper as [101]
The Abstract reports this randomized controlled trial and an earlier controlled trial of azithromycin for early syphilis; the Discussion says their findings suggest it may be a useful alternative to penicillin. Our copy does not report treponemicidal activity in animal studies, so that part of the claim is unsupported. Page numbers are unavailable in the indexed copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredAzithromycin as a single 2-g oral dose has been effective for treating primary and secondary syphilis among certain populations.
“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 [605]
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- Authors
- Hook III, E. W., Behets, F., Van Damme, K., Ravelomanana, N., Leone, P., Sena, A. C., Martin, D., Langley, C., McNeil, L., & Wolff, M.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- University of North Carolina System (US)
- Louisiana State University (US)
- Indiana University Indianapolis (US)
- Family Health International 360 (US)
- Emmes (United States) (US)
- Venue
- The Journal of Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-06
- Volume
- 201
- Issue
- 11
- Pages
- 1729-1735
- ISSN
- 0022-1899 (ISSN-L)
- 1537-6613
- OpenAlex
- W2050218182
- Cited by
- 121
- References
- 15
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 6 · 2023: 4 · 2022: 5 · 2021: 5 · 2020: 8 · 2019: 6 · 2018: 2 · 2017: 8 · 2016: 6 · 2015: 14 · 2014: 8 · 2013: 7 · 2012: 19
- FWCI
- 9.32
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- Funders
- United States Agency for International Development
- Pfizer
- Louisiana State University
- U.S. Public Health Service (N01 A1 75329)
- School of Medicine, Indiana University
- Topics
- Health Sciences › Medicine › Physiology › Syphilis Diagnosis and Treatment
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Historical Medical Research and Treatments
- Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
- Keywords
- early syphilis, azithromycin, benzathine penicillin G, serological cure, HIV-negative patients, adverse events, gastrointestinal adverse effects, sexually transmitted infections
- MeSH terms
- Adolescent, Adult, Anti-Bacterial Agents, Female, Humans, Male, Middle Aged, Penicillin G Benzathine, Syphilis, Treatment Outcome, Azithromycin, Young Adult
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