Azithromycin/Bicillin Syphilis
Summary
The purpose of this study is to determine if azithromycin, a drug approved for treatment of other infections, is as effective for syphilis (a sexually transmitted disease) as the standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55 years of age, with primary, secondary or early latent syphilis, will participate in this research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures will include blood samples, physical exams, and swabs of sores.
Timeline
- Start
- 2000-06
- Primary completion
- 2007-08
- Completion
- 2009-03
Outcome
Met primary endpoint
paper 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%). PMID 20402591 ↗
paper the efficacy of azithromycin at a dosage of 2.0 g administered orally was equivalent to that of benzathine penicillin G PMID 20402591 ↗
Publications
- Results Sena AC, Wolff M, Martin DH, Behets F, Van Damme K, Leone P, Langley C, McNeil L, Hook EW. Predictors of serological cure and Serofast State after treatment in HIV-negative persons with early syphilis. Clin Infect Dis. 2011 Dec;53(11):1092-9. doi: 10.1093/cid/cir671. Epub 2011 Oct 12.
- Results Hook EW 3rd, Behets F, Van Damme K, Ravelomanana N, Leone P, Sena AC, Martin D, Langley C, McNeil L, Wolff M. A phase III equivalence trial of azithromycin versus benzathine penicillin for treatment of early syphilis. J Infect Dis. 2010 Jun 1;201(11):1729-35. doi: 10.1086/652239.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 2 g | Oral |
| Comparator | Benzathine Penicillin | Small molecule | 2.4e+06 iu | Intramuscular |
| Comparator | Doxycycline | Small molecule | 100 mg | Oral |