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Single-dose azithromycin versus penicillin G benzathine for the treatment of early syphilis.
N Engl J Med. 2005 Sep 22; 353(12):1236-44.NEJM

Abstract

BACKGROUND

Pilot studies suggest that a single, 2-g oral dose of azithromycin may be an alternative to a 2.4-MU intramuscular dose of penicillin G benzathine in the prevention and treatment of syphilis. We evaluated the efficacy of treatment with azithromycin in a developing country.

METHODS

A total of 328 subjects, 25 with primary and 303 with high-titer (a titer of at least 1:8 on a rapid plasmin reagin [RPR] test) latent syphilis, were recruited through screening of high-risk populations in Mbeya, Tanzania, and randomly assigned to receive 2 g of azithromycin orally (163 subjects) or 2.4 million units of penicillin G benzathine intramuscularly (165 subjects). The primary outcome was treatment efficacy, with cure defined serologically (a decline in the RPR titer of at least two dilutions by nine months after treatment) and, in primary syphilis, by epithelialization of ulcers within one or two weeks.

RESULTS

The average age of participants was 27.0 years, 235 (71.6 percent) were female, and 171 (52.1 percent) were seropositive for human immunodeficiency virus. Cure rates were 97.7 percent (95 percent confidence interval, 94.0 to 99.4) in the azithromycin group and 95.0 percent (95 percent confidence interval, 90.6 to 97.8) in the penicillin G benzathine group (95 percent confidence interval for the difference, -1.7 to 7.1 percent), achieving prespecified criteria for equivalence. Cure rates were also similar three and six months after treatment in the two groups and in all subgroups. Cure rates at three months were 59.4 percent (95 percent confidence interval, 51.8 to 67.1) in the azithromycin group and 59.5 percent (95 percent confidence interval, 51.8 to 67.3) in the penicillin G benzathine group and at six months were 85.5 percent (95 percent confidence interval, 79.4 to 90.6) and 81.5 percent (95 percent confidence interval, 74.8 to 87.4), respectively.

CONCLUSIONS

Single-dose oral azithromycin is effective in treating syphilis and may be particularly useful in developing countries in which the use of penicillin G benzathine injections is problematic. However, recent reports of azithromycin-resistant Treponema pallidum in the United States indicate the importance of continued monitoring for resistance.

Authors+Show Affiliations

London School of Hygiene and Tropical Medicine, London. riednerg@emro.who.intNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16177249

Citation

Riedner, Gabriele, et al. "Single-dose Azithromycin Versus Penicillin G Benzathine for the Treatment of Early Syphilis." The New England Journal of Medicine, vol. 353, no. 12, 2005, pp. 1236-44.
Riedner G, Rusizoka M, Todd J, et al. Single-dose azithromycin versus penicillin G benzathine for the treatment of early syphilis. N Engl J Med. 2005;353(12):1236-44.
Riedner, G., Rusizoka, M., Todd, J., Maboko, L., Hoelscher, M., Mmbando, D., Samky, E., Lyamuya, E., Mabey, D., Grosskurth, H., & Hayes, R. (2005). Single-dose azithromycin versus penicillin G benzathine for the treatment of early syphilis. The New England Journal of Medicine, 353(12), 1236-44.
Riedner G, et al. Single-dose Azithromycin Versus Penicillin G Benzathine for the Treatment of Early Syphilis. N Engl J Med. 2005 Sep 22;353(12):1236-44. PubMed PMID: 16177249.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Single-dose azithromycin versus penicillin G benzathine for the treatment of early syphilis. AU - Riedner,Gabriele, AU - Rusizoka,Mary, AU - Todd,Jim, AU - Maboko,Leonard, AU - Hoelscher,Michael, AU - Mmbando,Donan, AU - Samky,Eleuter, AU - Lyamuya,Eligius, AU - Mabey,David, AU - Grosskurth,Heiner, AU - Hayes,Richard, PY - 2005/9/24/pubmed PY - 2005/9/28/medline PY - 2005/9/24/entrez SP - 1236 EP - 44 JF - The New England journal of medicine JO - N Engl J Med VL - 353 IS - 12 N2 - BACKGROUND: Pilot studies suggest that a single, 2-g oral dose of azithromycin may be an alternative to a 2.4-MU intramuscular dose of penicillin G benzathine in the prevention and treatment of syphilis. We evaluated the efficacy of treatment with azithromycin in a developing country. METHODS: A total of 328 subjects, 25 with primary and 303 with high-titer (a titer of at least 1:8 on a rapid plasmin reagin [RPR] test) latent syphilis, were recruited through screening of high-risk populations in Mbeya, Tanzania, and randomly assigned to receive 2 g of azithromycin orally (163 subjects) or 2.4 million units of penicillin G benzathine intramuscularly (165 subjects). The primary outcome was treatment efficacy, with cure defined serologically (a decline in the RPR titer of at least two dilutions by nine months after treatment) and, in primary syphilis, by epithelialization of ulcers within one or two weeks. RESULTS: The average age of participants was 27.0 years, 235 (71.6 percent) were female, and 171 (52.1 percent) were seropositive for human immunodeficiency virus. Cure rates were 97.7 percent (95 percent confidence interval, 94.0 to 99.4) in the azithromycin group and 95.0 percent (95 percent confidence interval, 90.6 to 97.8) in the penicillin G benzathine group (95 percent confidence interval for the difference, -1.7 to 7.1 percent), achieving prespecified criteria for equivalence. Cure rates were also similar three and six months after treatment in the two groups and in all subgroups. Cure rates at three months were 59.4 percent (95 percent confidence interval, 51.8 to 67.1) in the azithromycin group and 59.5 percent (95 percent confidence interval, 51.8 to 67.3) in the penicillin G benzathine group and at six months were 85.5 percent (95 percent confidence interval, 79.4 to 90.6) and 81.5 percent (95 percent confidence interval, 74.8 to 87.4), respectively. CONCLUSIONS: Single-dose oral azithromycin is effective in treating syphilis and may be particularly useful in developing countries in which the use of penicillin G benzathine injections is problematic. However, recent reports of azithromycin-resistant Treponema pallidum in the United States indicate the importance of continued monitoring for resistance. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16177249/Single_dose_azithromycin_versus_penicillin_G_benzathine_for_the_treatment_of_early_syphilis_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa044284?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -