Document Detail

Single-dose azithromycin versus penicillin G benzathine for the treatment of early syphilis.
MedLine Citation:
PMID:  16177249     Owner:  NLM     Status:  MEDLINE    
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.
Gabriele Riedner; Mary Rusizoka; Jim Todd; Leonard Maboko; Michael Hoelscher; Donan Mmbando; Eleuter Samky; Eligius Lyamuya; David Mabey; Heiner Grosskurth; Richard Hayes
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  353     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2005 Sep 
Date Detail:
Created Date:  2005-09-22     Completed Date:  2005-09-27     Revised Date:  2009-11-19    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1236-44     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2005 Massachusetts Medical Society.
London School of Hygiene and Tropical Medicine, London.
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MeSH Terms
Administration, Oral
Anti-Bacterial Agents / administration & dosage*,  therapeutic use
Azithromycin / administration & dosage*
Developing Countries
HIV Seropositivity / complications
Injections, Intramuscular
Penicillin G Benzathine / administration & dosage,  therapeutic use*
Proportional Hazards Models
Syphilis / complications,  drug therapy*
Grant Support
//Wellcome Trust
Reg. No./Substance:
0/Anti-Bacterial Agents; 1538-09-6/Penicillin G Benzathine; 83905-01-5/Azithromycin
Comment In:
N Engl J Med. 2005 Sep 22;353(12):1291-3   [PMID:  16177256 ]
N Engl J Med. 2006 Jan 12;354(2):203-5; author reply 203-5   [PMID:  16411292 ]
N Engl J Med. 2006 Jan 12;354(2):203-5; author reply 203-5   [PMID:  16411293 ]
N Engl J Med. 2006 Jan 12;354(2):203-5; author reply 203-5   [PMID:  16407519 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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